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Vertex Pharmaceuticals, Inc logo

Associate Director, GMP Operational Quality (QA Ops For QC)

Vertex Pharmaceuticals, IncBoston, MA

$156,600 - $234,800 / year

Job Description General Summary: The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. The role will also oversee team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams. This role requires collaborative interaction with cross-functional partners such as analytical and process development, clinical and commercial QC, and manufacturing operations to ensure the on-time closure of deviations, CA/PA, and change controls. This QA position will work with internal and external QA teams and QC labs ensuring adherence to compliance while supporting both clinical and commercial release and stability testing of a genetically edited cell therapy product. The position will provide compliance support to both clinical and commercial data review and data management. This person will support QA activities related to GMP release and stability as well as lifecycle improvement for methods related to raw material, in-process, and drug product samples. The GMP-facing nature of this work requires keen attention to detail and understanding of analytical compliance expectations. Key Duties and Responsibilities: Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms Enable team to achieve team goals/objectives and enable their individual career development Develop and maintain compliant quality processes to support GMP activities Oversee the QA support of Change Controls, GMP investigations and associated CAPAs. Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections. Support review of regulatory submissions, as applicable Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Lead and follow up on any QLT action items assigned. Identify and communicate risks and assist with risk mitigation plans as necessary Supports internal audit or external audit programs; assists in preparation of audit responses Provide comprehensive knowledge support for partner and regulatory agency audits Assist management team in budgeting and scheduling Responsible for the following activities related to people management responsibilities: Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding Performance Management (goals, monitoring, reviews); Monitoring /Supporting Employee Engagement and Retention; Succession Planning; Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs. Accountable to provide oversight of day to day team operations Assists with workforce planning/resource modeling and to update through forecasting activities Knowledge and Skills: In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing Demonstrated success in building high-performing teams and skilled at managing team and individual development Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections Supstantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva) Education and Experience: Seven (7) + years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in cGMP related industry, with four (4) or more years of work experience in proven leadership/supervision and experience within a sterile manufacturing site and sterilization activities. Preferred Master's degree or relevant comparable background. Required Experience Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.) Knowledge of standard microbiological procedures (sterility testing, environmental monitoring, bioburden, and bacterial endotoxin testing) Must have experience in ethylene oxide, steam sterilization, and gamma radiation requirements. #LI-onsite Pay Range: $156,600 - $234,800 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Posted 2 weeks ago

P logo

QA Release Technician I - 2Nd

Perrigo Company CorporateCovington, OH
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it. 2nd Shift- Monday- Friday, 12pm- 8pm. Scope of the Role Samples raw materials and assigns tests in LIMS according to approved SOPs, WIs and specifications. Coordinates disposition of the raw material prior to release for manufacturing use. Ensures that batches are manufactured according to approved SOP's, finished product meets specifications before releasing it to the market, and appropriate resolution to batches pending approval due to GMP errors or investigations. Confirms batch, creates batch file, and logs the batch record and any required samples, and manages batch records that are on an investigational, at risk, or hold status. Answers production questions and concerns regarding batch records. Experience Required High School Diploma or GED, with a minimum of two years' experience working in an FDA regulated industry. Excellent oral and written communication skills, and strong interpersonal skills. Thorough understanding of equipment operation and manufacturing processes. Demonstrated strong analytical skills, and ability to work independently against multiple deadlines. Thorough knowledge of SOPs, and be able to provide clear direction and interpretation to staff in multiple areas. Demonstrated understanding of and ability to apply cGMPs, and ability to recognize variances from cGMPs. Physical requirements: Consistently/Frequently- Stand, walk, Lifting up to 50 lbs., feel with hands/fingers, reach, grasp, move items/boxes Occasionally- Sit, lifting above shoulders and head less than 50 lbs., pull, push, climb ladders, climb stairs, stoop/bend, squat, kneeling, reach above shoulders and head,. Rarely- Twisting Environmental: Occasionally - exposure to loud noises/machinery and exposure to chemicals Rarely - enter confined spaces Other qualities: Constant - see (vision), Consistently/Frequently -, hear, ability to read and write, ability to interpret information, basic math skills, reading and writing in English. Simple problem solving and decision-making skills Occasionally- Ability to see colors correctly, Hear, intermediate math skills and problems solving for method troubleshooting Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo Nearest Major Market: Dayton Nearest Secondary Market: Cincinnati

Posted 1 week ago

Veeva Systems logo

Senior QA Engineer

Veeva SystemsPleasanton, CA

$80,000 - $150,000 / year

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva Systems is looking for a functional Senior QA Engineer with black box and automation testing experience to join our rapidly growing team. This is a hands-on position for delivering quality SaaS applications in the Commercial space into production. What You'll Do Ability to work in an agile, small team environment with a focus on speed and quality Create testing-related documentation, including test plans, test cases/scripts, and bug reports assessing quality and associated risk Mentor junior SQAs in QA methodologies and skills Work closely with the automation group to automate features for better regression coverage Develop deep expertise in the product Conduct QA tests and verify outcomes within schedules/timelines Work with software engineers, product managers, and other QA testers in an Agile team environment Requirements 7+ years relevant work experience, including software development and/or software test automation Understanding of Software QA methodologies, tools, and approaches (black box and/or automated testing) in a software company with short release cycles Experience in writing test cases and automating them, covering both sanity and in-depth testing including and not limited to boundary, negative, compatibility, and concurrency tests Working knowledge and experience in SQL database queries Strong expertise with Unix/Linux command line for log analysis Strong expertise with API testing tools (e.g., Postman) Strong verbal and written communication skills Bachelors / Master's degree in Computer Science, Software Engineering, or equivalent experience Must be located in the Pacific or Mountain Time Zones Nice to Have Experience with Jira, Confluence, and TestRail Experience in a SaaS environment that has an agile development process Perks & Benefits Medical, dental, vision, and basic life insurance Flexible PTO and company paid holidays Retirement programs 1% charitable giving program Compensation Base pay: $80,000 - $150,000 The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus. #LI-Remote Veeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com. Work Where It's Best for You Work Anywhere means you can work in an office or at home on any given day. It's about getting the work done in the way and place that works best for each person. This applies across all locations and departments. Work Anywhere does not mean work at any time. We have predictable core hours where employees are generally available for meetings and collaboration. Employees are focused and available during core hours. We invest in our offices to make them places where our employees like to go. If you work in the office three or more days a week, you will have a dedicated office workspace. Our offices function as hubs to draw people in, create social bonds, and where random connections and mixing of ideas happen. We're investing more in offices, culture, and offsite meetings, not less. Product teams are organized in regional product hubs for optimal collaboration and live within a time zone of their hub. Our current product hubs are located in Pleasanton, Columbus, Boston, Kansas City, New York City, Raleigh, and Toronto. We create opportunities for teams to get together in person regularly. Customer-facing roles, such as Sales and Professional Services, live near and/or travel to their customers. When an employee moves within a country it does not cause a change in salary. Where you live impacts you and your family. Not knowing if your compensation will change if you move can cause stress and uncertainty for everyone. We wanted to eliminate that. Work at Veeva. Work where it's best for you. A different kind of company. A Public Benefit Corporation. Unlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. × What sets us apart Public Benefit Corporation Work Anywhere Veeva Giving Corporate Citizenship Employees are Shareholders Non-Competes Public Benefit Corporation In February 2021, Veeva became the first public company to convert to a Public Benefit Corporation (PBC). Unlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. Veeva's public benefit purpose is to help make the industries we serve more productive and create high-quality employment opportunities. Learn More Work Anywhere Work Anywhere means you can work in an office or at home on any given day. It's about getting the work done in the way and place that works best for you. We invest in our offices to make them places where our employees like to go. If you work in the office three or more days a week, you will have a dedicated office workspace. Product teams are organized in regional product excellence hubs for optimal collaboration and live within a time zone of their hub. Our current product hubs are located in Pleasanton, Columbus, Boston, Kansas City, New York City, Raleigh, and Toronto. We create opportunities for teams to get together in person regularly. Customer-facing roles, such as Sales and Professional Services, live near and/or travel to their customers. Read More → Veeva Giving At Veeva, we believe in giving back. Veeva's support for charitable causes is entirely employee driven because we think giving is personal and should be directed by the individual. With our 1% Veeva Giving program, each employee receives an amount equivalent to 1% of their base salary annually to support the non-profit(s) of their choice. We don't dictate favored corporate causes or ask employees to donate to specific non-profits. We never support a charitable cause in exchange for commercial advantage or preferential treatment. Corporate Citizenship Veeva's core values - do the right thing, customer success, employee success, and speed - guide our decision making and define our culture. Doing the right thing means that we are concerned about more than just financial success and return to shareholders. We recognize a responsibility to customers, employees, environment, and society.As individuals, we pride ourselves on being good people who are honest, fair, and direct. We treat others with respect. As a company, we strive to be a good corporate citizen, a positive force in the business community, active in our communities, and an example to others. Read More → Employees are Shareholders Our equity program is designed to enable the vast majority of our employees to participate. Our unique approach to awarding equity grants allows our employees to be shareholders so they can benefit financially in the company's growth. Non-Competes Veeva has taken a strong stance against the use of non-compete agreements that can limit employee opportunities. We do not require our employees to sign non-compete agreements, and we have taken legal action to fight the unfair use of these agreements by other companies because we believe such agreements limit an employee's fundamental right to work where they choose. We believe in our people and want them to be successful here at Veeva or wherever their careers take them. Read More → News and recognition Veeva in Top 100 Most Reliable Companies Fastest-Growing Company for 5 Years, Future 50 for 2 Years New York's Noncompete Bill Is A 'Big Domino To Fall'-And The Broadest Ban Yet-In A Growing Movement Against Them Veeva's Peter Gassner Combine's Today's Execution with Tomorrow's Vision Grow, contribute and be recognized "Veeva's engineering teams take a pragmatic approach to software development. We offer an ideal environment for engineers who value focus, speed and integrity in their work." Jacob Marcus VP, Engineering "I appreciate that Veeva values autonomy over alignment. As a result, we get to make decisions as a small team and ship products faster." Shilpa Chandermohan Software Engineer "As a software engineer at Veeva, I'm proud to be doing meaningful work building clinical trial software that will benefit so many people." Durward Denham Software Engineer Previous Next Other related jobs Release Engineer QA & Release Engineering Raleigh, United States Posted 11 days ago Senior Engineering Manager in Test QA & Release Engineering Bend, United States Posted 11 days ago Senior Engineering Manager in Test QA & Release Engineering Pleasanton, United States Posted 11 days ago QA Engineer QA & Release Engineering Boston, United States Posted 14 days ago Release Engineering Manager QA & Release Engineering Toronto, Canada Posted 56 days ago QA Manager QA & Release Engineering Pleasanton, United States Posted 146 days ago Explore all roles at Veeva Search Jobs

Posted 30+ days ago

DPR Construction logo

Taxonomy Qa/Qc Support Admin - OES

DPR ConstructionRichmond, VA
Job Description The Taxonomy QA/QC Support Admin is a data‑driven support role that plays a key part in maintaining the accuracy and integrity of the Taxonomy team's product lifecycle management data. This position supports the end‑to‑end Taxonomy process by assisting with item mapping, validation, research, and quality control efforts across multiple data platforms. The ideal candidate is highly organized, detail‑oriented, and comfortable working with structured data to ensure all items are accurately researched, mapped, and maintained throughout the Taxonomy project lifecycle. Duties and Responsibilities Responsible for item mappings within the Taxonomy project. Primary focus on items for vendors that have initially passed through and were reviewed by QA/QC. Would review items via PowerBi, Sharepoint, and/or Excel. Responsible for item mapping for items from the Family of Companies. Weekly report from SPD & DBC via excel. Assist with the QA/QC of new items brought in through the Taxonomy project. Responsible to create new items as necessary and update all Taxonomy files. Support issue resolution as necessary. Expected to be involved and participate in team meetings, virtually or in person. Additional ad-hoc responsibilities as necessary. Required Skills and Abilities Proficient in Excel Strong organization skills and attention to details. Excellent written and verbal communication skills. Experience with Microsoft platforms. Education and Experience Experience in the Construction Industry. Experience with PLM. Experience with Construction related products. Physical Requirements Full time in office expected. Prolonged periods sitting at a desk and working on a computer. DPR Construction is a forward-thinking, self-performing general contractor specializing in technically complex and sustainable projects for the advanced technology, life sciences, healthcare, higher education and commercial markets. Founded in 1990, DPR is a great story of entrepreneurial success as a private, employee-owned company that has grown into a multi-billion-dollar family of companies with offices around the world. Working at DPR, you'll have the chance to try new things, explore unique paths and shape your future. Here, we build opportunity together-by harnessing our talents, enabling curiosity and pursuing our collective ambition to make the best ideas happen. We are proud to be recognized as a great place to work by our talented teammates and leading news organizations like U.S. News and World Report, Forbes, Fast Company and Newsweek. Explore our open opportunities at www.dpr.com/careers.

Posted 4 days ago

Veeva Systems logo

QA Engineer

Veeva SystemsPleasanton, CA

$70,000 - $120,000 / year

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva is looking for a QA Engineer for functional and some automation testing for a new product. You will help build a multitenant SaaS product. This is an exciting time joining this fast paced group. What You'll Do Create testing-related documentation, including test plans, test cases/scripts, and bug reports assessing quality and associated risk Develop deep expertise in the product Conduct QA tests and verify outcomes within schedules/timelines Work with software engineers, product managers, and other QA testers in an Agile team environment Work closely with the automation group to automate features for better regression coverage Partially developing and running automation scripts Requirements 5+ years of solid, years of relevant work experience, including understanding and analyzing database design, data flow, and business logic Design database test strategies and plans based on requirements Validate inserted, updated, or deleted data against business logic Check source-to-target data Write SQL queries to validate, Data integrity and consistency Validate user roles, access privileges, and data masking rules Experience with AWS Strong knowledge and experience in SQL Database testing Collaborate with developers, data analysts, and business analysts to understand data requirements and workflows. Strong verbal and written communication skills Understanding of Software QA methodologies, tools and approaches (functional and/or automated testing) in a software company with short release cycles Experience in creating testing-related documentation, including test plans, test cases/scripts, and bug reports assessing quality and associated risk Writing test cases and automating them, covering both sanity and in-depth testing including and not limited to boundary, negative, compatibility, end to end, and concurrency tests Work closely with the automation group to automate features for better regression coverage Conduct QA tests and verify outcomes within schedules/timelines Bachelor's in Mathematics or Computer Science/Applications or similar field Nice to Have Experience in Java, Python, or other object oriented programming language Experience with products like Jira, Confluence, Test Rail is an advantage Experience in a SaaS environment that has an agile development process is a huge plus Perks & Benefits Medical, dental, vision, and basic life insurance Flexible PTO and company paid holidays Retirement programs 1% charitable giving program Compensation Base pay: $70,000 - $120,000 The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus. #LI-Associate Veeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com. A different kind of company. A Public Benefit Corporation. Unlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. × What sets us apart Public Benefit Corporation Veeva Giving Corporate Citizenship Employees are Shareholders Non-Competes Public Benefit Corporation In February 2021, Veeva became the first public company to convert to a Public Benefit Corporation (PBC). Unlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. Veeva's public benefit purpose is to help make the industries we serve more productive and create high-quality employment opportunities. Learn More Veeva Giving At Veeva, we believe in giving back. Veeva's support for charitable causes is entirely employee driven because we think giving is personal and should be directed by the individual. With our 1% Veeva Giving program, each employee receives an amount equivalent to 1% of their base salary annually to support the non-profit(s) of their choice. We don't dictate favored corporate causes or ask employees to donate to specific non-profits. We never support a charitable cause in exchange for commercial advantage or preferential treatment. Corporate Citizenship Veeva's core values - do the right thing, customer success, employee success, and speed - guide our decision making and define our culture. Doing the right thing means that we are concerned about more than just financial success and return to shareholders. We recognize a responsibility to customers, employees, environment, and society.As individuals, we pride ourselves on being good people who are honest, fair, and direct. We treat others with respect. As a company, we strive to be a good corporate citizen, a positive force in the business community, active in our communities, and an example to others. Read More → Employees are Shareholders Our equity program is designed to enable the vast majority of our employees to participate. Our unique approach to awarding equity grants allows our employees to be shareholders so they can benefit financially in the company's growth. Non-Competes Veeva has taken a strong stance against the use of non-compete agreements that can limit employee opportunities. We do not require our employees to sign non-compete agreements, and we have taken legal action to fight the unfair use of these agreements by other companies because we believe such agreements limit an employee's fundamental right to work where they choose. We believe in our people and want them to be successful here at Veeva or wherever their careers take them. Read More → News and recognition Veeva in Top 100 Most Reliable Companies Fastest-Growing Company for 5 Years, Future 50 for 2 Years New York's Noncompete Bill Is A 'Big Domino To Fall'-And The Broadest Ban Yet-In A Growing Movement Against Them Veeva's Peter Gassner Combine's Today's Execution with Tomorrow's Vision Grow, contribute and be recognized "Veeva's engineering teams take a pragmatic approach to software development. We offer an ideal environment for engineers who value focus, speed and integrity in their work." Jacob Marcus VP, Engineering "I appreciate that Veeva values autonomy over alignment. As a result, we get to make decisions as a small team and ship products faster." Shilpa Chandermohan Software Engineer "As a software engineer at Veeva, I'm proud to be doing meaningful work building clinical trial software that will benefit so many people." Durward Denham Software Engineer Previous Next Other related jobs Release Engineer QA & Release Engineering Raleigh, United States Posted 9 days ago Senior Engineering Manager in Test QA & Release Engineering Bend, United States Posted 9 days ago Senior Engineering Manager in Test QA & Release Engineering Pleasanton, United States Posted 9 days ago QA Engineer QA & Release Engineering Boston, United States Posted 12 days ago Release Engineering Manager QA & Release Engineering Toronto, Canada Posted 54 days ago QA Manager QA & Release Engineering Pleasanton, United States Posted 144 days ago Explore all roles at Veeva Search Jobs

Posted 30+ days ago

S logo

QA Engineer II

Strata Decision Technology, LLCChicago, IL

$70,000 - $90,000 / year

How you'll make an impact: At Strata we are fueling the missions of lifeblood industries of our society: Healthcare, Financial Institutions, and Higher Education. As a QA engineer, you will work on financial planning software that allows financial institutions to plan and forecast for greater efficiency and effectiveness in their operations. You will become an expert in Strata's software and acquire a deep understanding of the technology driving the systems. In addition, you will collaborate with our development and consulting teams to ensure that the product is aligned with client needs and meets Strata's high quality of standards. To be successful in this role you must be passionate about QA, technical and like working in an Agile environment. Create and update test cases and test scenarios due to changes in product functionality Identify, document, and track defects found during testing Perform thorough regression testing when defects are fixed Design, develop and maintain automated tests where applicable Stay up to date on the latest processes and IT advancements to automate and modernize our systems Work in a scrum team following an agile software development process. Work effectively with cross-functional, distributed teams Evaluate product development and quality assurance processes, identify areas for improvement, and implement solutions that will have the greatest impact Develop comprehensive end-to-end test cases at the application level Work closely with product management to provide UI/UX feedback and share ideas for future product features and enhancements What we're looking for: 1-2 years of professional experience in software quality assurance. Excellent problem solving and analytical skills Strong experience with QA methodology Experience with one of the leading test automation tools and frameworks Experience with at least one object-oriented programming language Professional background in SQL and relational database concepts. Knowledge and experience working with Agile development methodology Understand entire software development life cycle from requirements gathering to delivery Strong self-motivation, and the ability to work effectively with limited guidance when necessary A drive to learn quickly and constantly adapt to new challenges Excellent written and verbal communication skills Strong interest in Healthcare/Financial Institutions industry and financial performance management, with a passion for making a difference in industry and society. Estimated Salary Range: $70,000 - $90,000 Actual salary will be determined based on factors including, but not limited to, skill set and level of experience. This salary range is a good faith estimate of base pay. Strata also provides discretionary variable pay programs based on role. In addition, Strata provides a comprehensive benefits package including retirement benefits, health and welfare benefits, paid time off, parental leave, life and accident insurance, and other voluntary and well-being benefits. Find out more about Strata benefits here. How we work: The preferred location for this role is in Chicago, IL or St. Louis, MO. We value our people spending time together and have campuses hosting in-person events located in both cities. We are truly a hybrid environment with all team members experiencing the flexibility to work from home. Thinking about applying? Research shows that women and underrepresented groups tend to apply to jobs only when they check every box on a job posting. If you're currently reading this and hesitating to click "Apply" for that reason, we encourage you to go for it! A true passion and excitement for making an impact is just as important as work experience. Should you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please reach out to careers@stratadecision.com. Here @ Strata… Our culture is driven by our people solving problems together. We embrace learning, collaboration, and continuous career growth. Together, we lift our customers, our products, our company, and our community. We believe that each of our team member's unique perspectives and experiences is what drives innovation and positive change. Our individual differences are what make us a more forward-thinking organization. We foster a culture of inclusion, equity and belonging, regardless of race, religion, disability, sex, sexual orientation, gender identity or national origin. Our Core Values: While we celebrate what makes each member of our team unique, our core values are what connect us. They set clear expectations for how we approach our work and how each of us can positively influence the experience of our team and our customers. We connect with positive intent. We are helpful. We own it. We get better every day. We are humble.

Posted 30+ days ago

Gate Gourmet logo

QA Manager

Gate GourmetLas Vegas, NV

$85,000 - $90,000 / year

We're looking for motivated, engaged people to help make everyone's journeys better. Position is responsible for food safety and quality engineering and control on processes supporting operation, system, policy and procedure auditing; leads quality improvement projects, drives defect prevention on flight attendant comments and detections. Acts as the primary business quality project manager for Corporate Quality Assurance requirements and regulations. Annual Hiring Range: $85,000- $90,000 Per Year Benefits Paid time off 401k, with company match Company sponsored life insurance Medical, dental, vision plans Voluntary short-term/long-term disability insurance Voluntary life, accident, and hospital plans Employee Assistance Program Commuter benefits Employee Discounts Free hot healthy meals for unit operations roles Must be able to pass a 20yr Background check through the Federal Bureau of Investigation (FBI) fingerprint-based Criminal History Records Check (CHRC) process at Harry Reid International Airport Main Duties and Responsibilities: Supports all customer and regulatory audits within the responsible facilities Works side-by-side with Operation Managers to assure compliance to HACCP requirements are met Works as part of the corrective action team to address non-conformities related to product, process and service Executes monthly self-assessments on the elements of food safety Executes the required food safety related testing as defined in HACCP plan Plans for quality (capital, supplier quality, plant quality). Evaluates and reports on performance trends related to quality Manages Quality Engineering projects, including operative supportive functions Leads and monitors improvement projects as assigned Audits implementation of quality systems for effectiveness by verifying activities Responsible for maintaining and managing the corrective action system Monitors the accuracy and compliance of HACCP records as defined in the corporate procedures Reinforces quality awareness to the management and work staff Schedules and manages the daily activities and task of the sanitation porters (if defined as a responsibility) Manages continuous improvement projects in quality elements Plays a key role in implementing the business management system Implements the quality system detailed in the quality manual Champions quality improvement efforts and initiates problem solving efforts and assures implementation Drives prevention vs. detection of defects tracking key performance indicators and daily patrol of production areas Responsible to lead product defect investigations Responsible to lead investigations of alleged food poisoning, Hard-foreign and soft foreign objects Responsible to manage the compliance with USDA / APHIS regulations Responsible to manage food product suppliers of the unit including auditing of local suppliers Coordinates actions to prevent the occurrences of nonconformities to internal, Federal and State laws Maintains customer compliance resolution on defects including alleged food poisoning if needed Responsible for the identifying and maintaining of key performance metrics for the Quality organization Continuously improves plant procedures for monitoring and ensuring conformance to specifications for incoming raw materials as well as for finished products Acts as the primary liaison to Corporate QA Compliance Team Plays a key role in training and coaching of quality requirements to all levels in the business unit's organization Responsible for safety, quality and compliance to customer specification Ensures optimum business processes to support full customer and regulatory compliance in terms of quality and food safety Stays attuned to and prepares adaptation to changes in customer, company and regulatory changes in requirements At times liaises with customers and regulatory agencies Responsible for performance evaluation, coaching, counseling and preparing corrective action for employees and liaises appropriately with HR and other support functions Completes Hazard Analysis and Risk Based Preventative Controls (HARPC) Preventative Controls for Human Food training and certification course to be a PCQI "Preventive Controls Qualified Individual" according to company policy. Completes all other company required training including but not limited to ServSafe Sanitation Manager Certification. Qualifications Education: Bachelor's degree in food science, quality, technical or business-related field from an accredited 4-year college or university required Work Experience: Minimum of 5 years quality assurance experience in a manufacturing environment, with preference in food manufacturing Job Skills: Advanced technical knowledge in catering processes and design functions, manufacturing methods, inspection, statistical methods and quality auditing Knowledge of lean standard tools, TQM methodology Basic lean, six sigma knowledge, and continuous improvement understanding a plus Detail oriented Project management experience Strong organizational skills, able to prioritize responsibilities and multi-task Technical Skills: (Certification, Licenses and Registration) ServeSafe certification preferred HACCP certified Language / Communication Skills: Strong interpersonal skills, interact well with multiple departments as required Able to work with little supervision Excellent reading, writing, and oral communication skills Multi-lingual a plus Job Dimensions Geographic Responsibility: US Type of Employment: Full time Travel %: 20% Exemption Classification: Exempt Internal Relationships: External Relationships: Work Environment / Requirements of the Job: Regularly stands, bends, lifts and moves intermittently during shifts. Must be to lift, pull, push, and move products, equipment, and supplies daily. There may be physical discomfort due to temperature in production area, coolers, and freezers Budget / Revenue Responsibility: Organization Structure Direct Line Manager (Title): General Manager Dotted Line Manager (Title, if applicable): Sr. Compliance Manager Number of Direct Reports: Number of Dotted Line Reports: Estimated Total Size of Team: gategroup Competencies Required to be Successful in the Job: Thinking- Information Search and analysis & problem resolution skills Engaging- Understanding others, Team Leadership and Developing People Inspiring- Influencing and building relationships, Motivating and Inspiring, Communicating effectively Achieving- Delivering business results under pressure, Championing Performance Improvement and Customer Focus Demonstrated Values to be Successful in the Position Employees at gategroup are expected to live our Values of Excellence, Integrity, Passion and Accountability. To demonstrate these Values, we expect to observe the following from everyone: We treat each other with respect and we act with integrity We communicate and keep each other informed We put our heads together to problem solve and deliver excellence as a team We have passion for our work and we pay attention to the little details We foster an environment of accountability, take responsibility for our actions and learn from our mistakes We do what we say we will do, when we say we are going to do it We care about our coworkers, always taking an opportunity to make someone's day better The above statements are intended to describe the general nature and level of work being performed by the individual(s) assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. Management reserves the right to modify, add, or remove duties and to assign other duties as necessary. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. gategroup is an equal opportunity employer committed to workforce diversity. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status or other category under applicable law. For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf We anticipate that this job will close on: 02/18/2026 For California Residents, please click here to view our California privacy notice. If you want to be part of a team that helps make travel and culinary memories, join us!

Posted 2 days ago

Broadcom Corporation logo

Software QA Engineer

Broadcom CorporationSan Jose, CA

$141,300 - $226,000 / year

Please Note: If you are a first time user, please create your candidate login account before you apply for a job. (Click Sign In > Create Account) If you already have a Candidate Account, please Sign-In before you apply. Job Description: Ethernet NIC product portfolio is designed for high performance computing and networking applications including AI and ML. This is driven by the growing need for high server bandwidth, highest throughput and lowest latency networks. The NIC team is involved in the development of the next generation of Ethernet NIC solutions for AI/ML and High performance computing applications. We are looking for excellent QA engineers to join the NIC product team. As a Software QA Engineer, you will be responsible for validation of the RDMA protocol features for the Ethernet NIC. You will work cross functionally with marketing, architects, silicon development and the SW teams to document, test and automate high quality software, drivers and the firmware components. Responsibilities: Define and publish test plans for the RDMA protocol features for the Ethernet NIC products. Work closely with the architecture teams, silicon design teams and other software / firmware teams to design and execute performance and scale testing. Hands-on in test planning, automation and validation of RDMA protocol features to deliver high quality, high performance and functionally excellent products. Work closely with the SW team for a better test coverage and execution in the product release cycle. Work closely with the customer support engineers on any customer field issues and provide timely help for issue reproductions and closure. Requirements: BS/MS in Computer Science, Electronics & Communications or equivalent with minimum 12+ years of experience. Significant experience in RDMA protocol, QoS, Packet Classifications, Linux Systems programming, Linux kernel, Linux Network Drivers, Linux Kernel Networking, Virtual Switching and Data center Networking, and firmware development and testing. A good understanding of the RDMA protocol is a must have. Hands-on experience with RDMA is highly desired. Experience in writing test scripts to verify NIC behavior is highly desired. Excellent programming skills in Python is a must. Strong analytical, problem solving and debugging skills in a combined software and hardware environments. Excellent written and verbal communication skills, ability to efficiently collaborate with multiple teams across geographically diverse areas. Additional Job Description: Compensation and Benefits The annual base salary range for this position is $141,300 - $226,000 This position is also eligible for a discretionary annual bonus in accordance with relevant plan documents, and equity in accordance with equity plan documents and equity award agreements. Broadcom offers a competitive and comprehensive benefits package: Medical, dental and vision plans, 401(K) participation including company matching, Employee Stock Purchase Program (ESPP), Employee Assistance Program (EAP), company paid holidays, paid sick leave and vacation time. The company follows all applicable laws for Paid Family Leave and other leaves of absence. Broadcom is proud to be an equal opportunity employer. We will consider qualified applicants without regard to race, color, creed, religion, sex, sexual orientation, national origin, citizenship, disability status, medical condition, pregnancy, protected veteran status or any other characteristic protected by federal, state, or local law. We will also consider qualified applicants with arrest and conviction records consistent with local law. If you are located outside USA, please be sure to fill out a home address as this will be used for future correspondence.

Posted 30+ days ago

Farmer Focus logo

QA Supervisor - 2Nd Shift Acorn

Farmer FocusHarrisonburg, VA
Who We Are and What We Do Farmer Focus's mission is to promote and protect generational family farms by shifting farm-level decision-making and chicken ownership back to farmers and empowering them to farm the way they know is best. We are committed to consistently producing 100% organic and humanely raised chicken that is better for people, the planet, and animals. Our culture is rooted in servant leadership, and we live by our Farmer Focus CARES values: Community, Accountability, Respect, Excellence, and Stewardship. Who We Are and What We Do Farmer Focus's mission is to promote and protect generational family farms by shifting farm-level decision-making and chicken ownership back to farmers and empowering them to farm the way they know is best. We are committed to consistently producing 100% organic and humanely raised chicken that is better for people, the planet, and animals. Our culture is rooted in servant leadership, and we live by our Farmer Focus CARES values: Community, Accountability, Respect, Excellence, and Stewardship. How this role will be impactful The Food Safety Quality Assurance Supervisor is responsible for leading and driving the continuous improvement of the Quality Assurance tech team. Identifying, developing, and maintaining all Farmer Focus Quality and Food Safety policies. Verifying all AQL/SSOP/HACCP paperwork, the plant GMP's, and other pre-requisite programs daily. Maintaining a strong and positive relationship with USDA. Proactively monitoring the production floor to identify problems before they develop and implement strategies for improvement of processes. Contributes execution of product food safety and quality programs to support the organization's goals of operational excellence and customer/client satisfaction. Responsible for supervising the Quality Assurance technician's day to day performance and productivity Assisting Quality Assurance Manager in projects and delegated tasks. Ensures complete traceability of incoming raw materials and finished product while managing lot code tracking Involved in food safety audits as requested. Provides/coordinates training of production personnel in making quality measurements and developing core quality competencies. Develop programs and procedures to ensure regulatory and SVO Food Safety requirements are met and maintained. Train QA team members prior to implementation of all programs and procedures. Update, Manage, and Maintain the SSOP/HACCP and other pre-requisite programs in an organized and effective manner. Audit all SSOP/HACCP records providing timely feedback to management. Maintain a positive relationship with the USDA and keep up with the regulations concerning SSOP/HACCP program. Training and documentation of training of all levels of plant team members concerning SSOP/HACCP/GMP programs. Hands on involvement in all Quality and Food Safety problems that arise during the shift and developing appropriate solutions and corrective actions/preventative measures for those problems. What You Bring to the Role B.S. or B.A. degree (or equivalent) in Food Science, Meat Science, Poultry Science, or related field required. Over 4+ years of relevant experience in a comparable position. HACCP Certification preferred Strong analytical and problem-solving abilities to identify and resolve quality issues. Cross-functional team leadership skills including the ability to coaching/mentoring. Efficient in Microsoft Word, Excel, Outlook, UltiPro, and Workday Work Environment: Must be able to work in a variety of settings including the office, outside grounds, and the Plant production floor. Possibility of being exposed to varying conditions in the Plant setting, such as cold areas, warm areas, chemicals, and other site conditions. Farmer Focus is committed to the principles of equal employment and to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment that is inclusive and equitable, free of harassment, discrimination, or retaliation based upon an individual's age, race (including traits historically associated with race, which includes hair texture, hair type, and protective hairstyles such as braids, locks, and twists), color, national origin, ancestry, religion, sex, sexual orientation (including transgender status, gender identity, or expression), pregnancy (including childbirth, lactation, and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), military status (including status as a uniformed servicemember, a veteran, or dependent of a servicemember), or any other status protected by federal, state, or local laws. Farmer Focus is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay and other compensation, termination, and all other terms, conditions, and privileges of employment.

Posted 30+ days ago

B logo

Sr. Manager, QA Operations - Product Release

BridgeBio Pharma, Inc.San Francisco, CA
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. What You'll Do Manage lot release activities at the company's Contract Manufacturing Organizations (CMOs). The individual will act as QA Operations lead with assigned CMOs, including review of manufacturing batch records, certificates of analysis and the issuance of certificates of compliance. The Sr. Manager, QA Operations- Product Release will ensure that the CMO SOPs and Master Batch Records are in compliance with cGMPs and will serve as the technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates, as needed. Responsibilities Represent QA Operations on internal and external project teams, audits and inspections, and participate in monitoring of CMO performance. Review and manage master and executed manufacturing batch records from CMOs, including release activities, and related documents such as specifications, analytical and microbiological methods, stability study/protocols, process and method validation protocols and reports. Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.). Lead disposition of Drug Substance (DS), Drug Product (DP) and Finished Product (FP). Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution Support review of regulatory filings Support audit of CMOs Where You'll Work This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office or a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Who You Are Bachelor's Degree in a science discipline with 8+ years of experience within a biopharmaceutical company, or contract research organization Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA), ICH and GxP principles General knowledge of FDA and other global clinical trial regulations Prior experience in QC, Analytical Development and process validation highly desired Excellent verbal and written communication skills, with a strong customer focus Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail Travel up to 10% total time You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave- 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities #LI-SG1

Posted 2 weeks ago

Smithfield Foods, Inc. logo

Food Safety & QA Supervisor - 2Nd Shift

Smithfield Foods, Inc.Smithfield, VA
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now! THE VALUE YOU'LL BRING: The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section. As part of our Food Safety & Quality Assurance team, you will ensure our products meet the highest safety and quality standards. You will conduct sanitation checks, enforce HAACP and USDA regulations, and track products from start to finish, implementing corrective actions as needed. Overseeing FSQA programs in specific production areas, you will ensure compliance, train employees, and drive continuous improvement. With opportunities to step into FSQA Manager duties, you will play a vital role in delivering safe, high-quality products under brands like Smithfield, Eckrich, and Nathan's Famous. If you are passionate about food safety, quality and leadership, join us and make an impact! WHAT YOU'LL DO: The below statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned. Food Safety & Quality Assurance Leadership- You'll ensure that all Food Safety, Quality Assurance, SQF, and Regulatory programs are executed and documented accurately, maintaining compliance and product integrity. Your role will involve investigating and resolving product/process failures quickly, minimizing downtime, and ensuring safety and quality standards are consistently met. You will collaborate closely with plant management, production teams, and the USDA to drive continuous improvement in food safety, quality, and sanitation. Continuous Improvement & Compliance- You'll prevent failures by actively managing HACCP, SSOP, and product specifications. Leading efforts to improve product quality and processes in partnership with FSQA staff and Operations will be a key responsibility. Additionally, you will oversee and participate in plant committees and task forces, such as the Health and Safety Committee, to enhance safety and quality standards. Sanitation & SQF System Ownership- You will conduct operational and pre-operational sanitation inspections and micro sampling to ensure the effectiveness of sanitation practices. As the owner of the SQF system, you'll maintain and reassess the SQF Plan regularly, ensuring it remains compliant and up to date. You will also communicate key updates and ensure team-wide awareness for the effective implementation of the SQF system. Team Development- You'll manage the work assignments, training, and development of food safety and quality assurance staff, fostering a high-performance team that upholds the highest standards of food safety and quality. WHAT WE'RE SEEKING: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Bachelor's degree from an accredited four-year college or university and 2+ years' relevant experience in food safety or quality assurance; or equivalent combination of education and experience. Experience acting as a lead by providing training, coaching or mentoring to less experienced staff or through managing a process or project. Familiarity with meat processing, USDA, HACCP, SSOP, and SQF Ability to uphold regulatory, company, and customer standards and address inquiries or complaints. OTHER SKILLS THAT MAKE YOU STAND OUT: HACCP and SQF certifications preferred. Ability to uphold regulatory, company, and customer standards and address inquiries or complaints. Proficiency in database, inventory, manufacturing software, QMS systems, SAP, and MS Office. Strong written and oral communication, with excellent decision-making and problem-solving abilities. Strong planning, multitasking, and project management skills. Must complete forms in English; ability to travel up to 20% and work extended hours or weekends as needed. Ability to work effectively in a fast-paced environment, fostering positive relationships and a team-oriented atmosphere. PHYSICAL DEMANDS & WORK ENVIRONMENT: The physical demands described here are representative of those an employee should possess to successfully perform the essential functions of this job. The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Office and plant setting. The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals. Occasionally lift and/or move up to 50 pounds Specific vision includes close vision, distance vision, and ability to adjust focus. Additionally ability to differentiate colors. Frequently required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. Noise level in the work environment is usually moderate but can be loud when in the production area. Relocation Package Available No EEO Information Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Posted 1 week ago

L logo

QA Shop Floor Specialist

Legend Biotech CorpRaritan, NJ

$81,273 - $106,669 / year

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Sun-Wed 1st Shift Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review & material release in SAP for In-house reagents. Support Floor Spot-check, audit trail review. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Responsibilities will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses Color Perception both eyes 5 slides out of 8. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements Bachelors degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. Experience with quality support in clinical manufacture is preferred. Flexible to work on weekends, as needed. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. Ability to lift 20 lbs. Report to work on-time. Duties are required to be performed on-site at manufacturing facility. Perform other duties as assigned. Attend departmental and other scheduled meetings. Practice good interpersonal and communication skills. Demonstrate positive team-oriented approach in the daily execution of procedures. Promote and work within a team environment. Learn new skills, procedures and processes as assigned by management and continue to develop professionally. Support and contributes to projects. Assist in troubleshooting issues related to manufacturing. Technical knowledge within functional units Demonstrate an understanding of the process in order to properly perform the assigned tasks. Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. Utilizes tools within MS Office and other systems to improve business effectiveness. Read and interpret documents such as safety rules, operating instructions, and logbooks. Review and provide feedback for SOPs. Interpret a variety of instructions furnished in written, oral, or diagram. Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #LI-BG1 #LI-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is: $81,273-$106,669 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.

Posted 30+ days ago

KBI Biopharma logo

Principal QA Specialist - Batch Disposition

KBI BiopharmaDurham, NC
Position Summary: Roles is responsible for performing, managing, and tracking deliverables for batch disposition to include compiling batch and batch linked documentation required for final and conditional product release, accurately maintaining site tracking and communication trackers, and providing accurate disposition statuses to clients, site departments, and Site / Executive Leadership. The role interfaces and collaborates with clients, Project Management, Manufacturing, QC, Supply Chain, Facilities/Engineering and internal QA departments to set disposition priorities, execute disposition elements and meet disposition timelines. Additionally, the role tracks, trends, and reports QA batch release metrics at relevant operational meetings and to Senior Leadership as well as leads internal cross-functional batch disposition meetings: identifying and tracking actionable items and escalating / informing to assure resolution of obstacles. Supports external client review and resolution of comments related to batch documentation, deviations, and CAPAs as needed. Responsible for gathering and presenting data for disposition and relevant metrics to management. Position Responsibilities: Tracks, monitors, and reports on status of Batch disposition for each product. Maintains and reports related to metrics. Trends, reports on batch disposition and other area data. Reviews batch documentation and approve relevant documents as the QA Approver. Compiles final packages. Works directly with Manufacturing, Engineering, MS&T (Manufacturing Science and Technology), Quality Control, Quality Assurance, Supply Chain and Validation to resolve issues to support commercial and clinical batch disposition. Interfaces with the client. Reviews deviations, CAPA's, Interim Reports and ECs as needed. Completes Change Controls, master and executed Batch Records, and technical documents including CPV reports upon need. Initiates, manages Quality Change Controls as needed. Supports Annual Product Review, Complaint process (Supplier Quality, Product), Internal and client Inspections. Performs as disposition and complaint SME during regulatory and Health Authority Inspections. Performs as back-up for Client Support as a Point of Contact (POC), working closely with the PM team, attending client / KBI Quality to Quality meetings, compiles disposition and document status for meetings; develops related presentations. Supports manufacturing, Supply Chain and Quality to improve and streamline relevant Quality systems, business processes, and manufacturing processes. Executes other assignments upon request. Minimum Requirements: BS and 18+ years' experience or MS and 15+ years' experience in a cGMP regulated environment within Biopharmaceuticals or equivalent. Experience with Quality Systems to include batch record review, batch disposition of biopharmaceuticals, and investigations and CAPAs. Knowledge of US, EU, and Row cGMP guidelines required. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 4 days ago

Técnico Corporation logo

Corporate QA & ESH Manager

Técnico CorporationChesapeake, VA
Position Summary Oversees and evaluates the daily responsibilities of Quality Inspectors to ensure adherence to the Quality Management System. Guarantees consistent quality production through process verification and documentation review. Engages with cross-functional teams to uphold quality standards. Develops and maintains quality evaluation and control systems and protocols to align with customer specifications and requirements. Essential Duties and Responsibilities Ensures adherence to the organization's Quality Management System (QMS), production standards, and customer specifications. Oversees and orchestrates the operations and procedures of the Quality Assurance department, as well as the daily activities and responsibilities of direct reports. Oversees Quality Assurance team members ensuring strong performance and operational success. Administers performance reviews, coaching, and development activities as necessary. Manages the internal audit program to ensure adherence to company policies and procedures. Engages in external audits to assess the suitability of suppliers for utilization. Provides employee training and technical leadership. Manages the organization's corrective action program, encompassing both Corrective Action and Preventative Action requests associated with production activities, to ensure adherence to established policies, procedures, and work instructions. Oversees the non-destructive testing (NDT) program, ensuring compliance with inspector certifications, conducting surveillance of ongoing welding processes, and reviewing weld packages for quality assurance. Manages the calibration processes and oversees programs related to non-conforming materials. Facilitates, documents, and ensures compliance with training programs as required by the Quality Management System (QMS). Provide health and safety leadership and direction to Division, Department, Branch Offices and Project Managers. Serve as the corporate environmental, health and safety subject matter expert with clients, regulators, and Company staff working on projects or designing proposal responses. Manage environmental, health and safety resources and related departmental budgets. Manage corporate environmental, health and safety staff. Consistently demonstrates punctuality, adheres to management directives, fosters positive collaboration with colleagues, complies with organizational policies and procedures, and actively contributes to achieving team and company goals with initiative and commitment. Other duties as assigned, requested or needed. Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Education and Experience: Bachelor's degree or equivalent education and 5 years' experience (military/marine or ship repair industry preferred). Knowledge, Skills and Abilities: Working knowledge of shipyard, maritime, preferred. Possessing a comprehensive understanding of Navy ship repair processes and procedures is highly desirable. Knowledge of NAVSEA standard items, the Joint Fleet Maintenance Manual, NAVSHIPS Technical Manuals, Department of Defense standards, and military specifications is highly advantageous. Ability to work at a high level of accuracy and attention to detail. Ability and tolerance to meet due dates and deadlines and/or time constraints. Ability to evaluate and analyze departmental and industry trends. Knowledge of and ability to utilize Microsoft office applications. Ability to resolve complaints and negotiate with others.

Posted 30+ days ago

Eko Health logo

Senior QA Engineer

Eko HealthEmeryville, CA

$128,000 - $144,000 / year

Eko builds AI and digital tools to enable every healthcare provider to more accurately detect heart and lung disease - the leading causes of death globally. Our FDA cleared, industry leading products are used by hundreds of thousands of clinicians on millions of patients around the world. With Eko, clinicians can detect cardiac and pulmonary disease with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible. We have strong venture capital backing from investors like Artis Ventures, Questa Capital, Highland Capital, and Mayo Clinic Ventures. Recognized by TIME magazine in 2025 as one of the world's top healthcare technology companies, Eko is one of the fastest growing digital health companies with products used around the world at some of the most prestigious health systems. We have more than 8 FDA clearances including novel AI algorithms, and we invest heavily in quality clinical research and R&D to build and validate exceptional products for patients we care deeply about. We've built a mission driven, high performing, talented, and diverse team of engineers, physicians, PhD's, creatives, and technologists. We are committed to investing in each other and our mission to ensure all patients have access to high quality care. We are headquartered in Emeryville, California and privately-held with world class investors and partners. We are seeking an experienced Senior Software Test Engineer (Mobile QA) to lead quality initiatives for our iOS and Android applications. This role is ideal for someone passionate about mobile user experience, automation, and delivering high-quality apps in fast-paced, Agile environments. As Senior QA Engineer at Eko, You Will: Own end-to-end quality for mobile applications across iOS and Android platforms Define and execute mobile test strategies, including functional, regression, integration, and exploratory testing Perform thorough testing across multiple devices, OS versions, and form factors Validate mobile-specific behaviors including offline mode, backgrounding, interruptions, network changes, and permissions Test integrations with backend services, APIs, Bluetooth, sensors, and third-party SDKs Collaborate closely with Product, Design, and Engineering to ensure testability and quality from early development stages Drive release readiness, sign-offs, and post-release validation for App Store and Play Store submissions Mentor junior QA engineers and establish mobile QA best practices Track quality metrics and continuously improve testing efficiency and coverageNote: Job duties may change at any time with or without notice. As Senior QA Engineer at Eko, You Have: Bachelor's degree in Computer Science, Engineering, or equivalent experience 6+ years of industry experience in software testing, with strong focus on mobile QA Hands-on experience testing native iOS and/or Android applications Solid understanding of mobile SDLC, Agile/Scrum methodologies, and CI/CD pipelines Ability to debug issues using logs, network inspectors, and device tools Excellent communication and collaboration skills As Senior QA Engineer at Eko, Preferred Qualifications: Knowledge of performance, security, and accessibility testing on mobile platforms Experience with Bluetooth, audio, sensors, or hardware-integrated mobile apps Familiarity with App Store / Play Store submission and compliance processes Experience in regulated domains (e.g., healthcare, fintech) is a plus Experience with CI/CD integration for mobile automation and knowledge of Automation Frameworks Benefits and Perks We Offer: The opportunity to work on products that impact the health of millions of people. Generous paid-time off Stock incentive plans Medical/Dental/Vision, Disability + Life Insurance One Medical membership Parental Leave 401k Matching Wellness programs and perks (Headspace, Ginger, Aaptiv, Physera) Learning and Development stipend $128,000 - $144,000 a year Compensation is market-based and reflects the cost of labor across different U.S. geographic locations. The specific salary is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Eko is proud to be an equal opportunity employer and welcome people of different backgrounds, experiences, abilities and perspectives. We are committed to building a diverse and inclusive team. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Posted 1 week ago

Genalyte logo

QA Tester - Temp

GenalyteSan Diego, CA

$35 - $45 / hour

ABOUT GENALYTE At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities. POSITION SUMMARY The QA Tester is responsible for executing test plans, identifying defects, and helping ensure software products meet quality standards before release. This role works closely with developers, product managers, and QA team members to verify functionality, usability, performance, and reliability. The ideal candidate is detail-oriented, organized, and eager to learn software testing best practices in a fast-paced environment. The QA Tester will also help ensure compliance with regulatory requirements, maintain quality system processes, and support the development of IVD products. This is a temporary position, and we are seeking to fill three openings through this posting. ESSENTIAL FUNCTIONS & RESPONSIBILITIES These may include but are not limited to: Execute manual test cases, collect evidence, and document test results clearly and accurately Identify, log, and track software defects using issue-tracking tools (e.g., Jira, Azure DevOps, etc.) Perform regression tests to verify bug fixes and updated features Assist in developing and maintaining test cases, test scripts, and test documentation Collaborate with developers to reproduce issues and clarify expected behavior Participate in sprint planning, reviews, and daily stand-ups (if Agile) Perform functional, regression, smoke, and exploratory testing Help ensure software meets user requirements and acceptance criteria Contribute to continuous improvement of QA processes: Review requirements, specifications, and technical design documents to provide timely and meaningful feedback to test developers. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES: Education: BS/MS degree in Computer Science, Engineering, or a related subject (or equivalent hands-on experience). Technical Proficiency: Familiarity with bug tracking tools (e.g., Jira) and test management software. Analytical Mindset: Ability to think through complex "edge cases" where a system might fail. Communication: Excellent written and verbal communication skills; you must be able to explain technical flaws to non-technical stakeholders. Experience: 2+ years of experience in software quality assurance testing or a related field. Preferred Qualifications: Experience with automated testing tools like Selenium, Cypress, or Playwright. Exposure to Agile/Scrum development environments Knowledge of SQL, APIs, or web technologies (HTML, CSS, JavaScript) (Python, JavaScript, Postman) Preferred Skills & Competencies Problem-solving mindset Strong written and verbal communication Organization and time management Curiosity and willingness to learn Ability to follow test procedures precisely Understanding of software validation concepts Experience working under FDA, ISO 13485, or similar quality systems Familiarity with documentation requirements and traceability The base range for this role is $35 - $45 per hour. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training.

Posted 2 weeks ago

Veeva Systems logo

Associate QA Engineer

Veeva SystemsPleasanton, CA

$67,000 - $100,000 / year

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva Systems is looking for a functional Associate QA Engineer to join our rapidly growing team that is focused on Vault CRM. This is a hands-on position for delivering quality SaaS products into production. What You'll Do Create test cases/scripts from design and requirements documents Work with software engineers and product managers in an Agile team environment Document test cases and test execution results in test case management application Conduct QA tests and verify outcomes within schedules/timelines Clearly document and explain defects found in the defect tracking system Requirements Bachelor's degree in Engineering or Science Attention to detail and problem-solving skills Must be in the Pacific or Mountain Time Zones Applicants must have the unrestricted right to work in the United States. Veeva will not provide sponsorship at this time Nice to Have QA internship or some QA experience is a plus Perks & Benefits Medical, dental, vision, and basic life insurance Flexible PTO and company paid holidays Retirement programs 1% charitable giving program Compensation Base pay: $67,000 - $100,000 The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus. Veeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com. A different kind of company. A Public Benefit Corporation. Unlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. × What sets us apart Public Benefit Corporation Veeva Giving Corporate Citizenship Employees are Shareholders Non-Competes Public Benefit Corporation In February 2021, Veeva became the first public company to convert to a Public Benefit Corporation (PBC). Unlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. Veeva's public benefit purpose is to help make the industries we serve more productive and create high-quality employment opportunities. Learn More Veeva Giving At Veeva, we believe in giving back. Veeva's support for charitable causes is entirely employee driven because we think giving is personal and should be directed by the individual. With our 1% Veeva Giving program, each employee receives an amount equivalent to 1% of their base salary annually to support the non-profit(s) of their choice. We don't dictate favored corporate causes or ask employees to donate to specific non-profits. We never support a charitable cause in exchange for commercial advantage or preferential treatment. Corporate Citizenship Veeva's core values - do the right thing, customer success, employee success, and speed - guide our decision making and define our culture. Doing the right thing means that we are concerned about more than just financial success and return to shareholders. We recognize a responsibility to customers, employees, environment, and society.As individuals, we pride ourselves on being good people who are honest, fair, and direct. We treat others with respect. As a company, we strive to be a good corporate citizen, a positive force in the business community, active in our communities, and an example to others. Read More → Employees are Shareholders Our equity program is designed to enable the vast majority of our employees to participate. Our unique approach to awarding equity grants allows our employees to be shareholders so they can benefit financially in the company's growth. Non-Competes Veeva has taken a strong stance against the use of non-compete agreements that can limit employee opportunities. We do not require our employees to sign non-compete agreements, and we have taken legal action to fight the unfair use of these agreements by other companies because we believe such agreements limit an employee's fundamental right to work where they choose. We believe in our people and want them to be successful here at Veeva or wherever their careers take them. Read More → News and recognition Veeva in Top 100 Most Reliable Companies Fastest-Growing Company for 5 Years, Future 50 for 2 Years New York's Noncompete Bill Is A 'Big Domino To Fall'-And The Broadest Ban Yet-In A Growing Movement Against Them Veeva's Peter Gassner Combine's Today's Execution with Tomorrow's Vision Grow, contribute and be recognized "Veeva's engineering teams take a pragmatic approach to software development. We offer an ideal environment for engineers who value focus, speed and integrity in their work." Jacob Marcus VP, Engineering "I appreciate that Veeva values autonomy over alignment. As a result, we get to make decisions as a small team and ship products faster." Shilpa Chandermohan Software Engineer "As a software engineer at Veeva, I'm proud to be doing meaningful work building clinical trial software that will benefit so many people." Durward Denham Software Engineer Previous Next Other related jobs Release Engineer QA & Release Engineering Raleigh, United States Posted 15 days ago Senior Engineering Manager in Test QA & Release Engineering Bend, United States Posted 15 days ago Senior Engineering Manager in Test QA & Release Engineering Pleasanton, United States Posted 15 days ago QA Engineer QA & Release Engineering Boston, United States Posted 18 days ago Senior Software Engineer in Test QA & Release Engineering San Luis Obispo, United States Posted 35 days ago Release Engineering Manager QA & Release Engineering Toronto, Canada Posted 60 days ago Explore all roles at Veeva Search Jobs

Posted 30+ days ago

A logo

QA Batch Record Review I

American Regent LaboratoriesShirley, NY

$21 - $24 / hour

Nature and Scope This position is responsible for providing the Quality Assurance review associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Procedures. The Batch Record reviewer ensures all documentation, processes and products meet specifications and that Batch Records are completed in accordance with GMP requirements. This position requires effective collaboration with other departments on production issues/situations, product dispositions and investigations. The Batch Record reviewer works under the direct supervision of the QA Supervisor. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Execute timely reviews all batch documentation for accuracy and completeness according to cGMP's. Execute batch record review and review of supporting systems including Veeva Vault and Trackwise. Adheres to internal and external guidelines, specifications and regulatory requirements while reviewing batch documentation. Ensures all work in performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements. Work with area personnel to resolve errors and/or discrepancies. Assures all errors and corrections are resolved according to SOP requirements. Enter data into applicable spreadsheets/databases. Update metric reporting as needed. Submit error free batch records to release for product shipments. Execute batch record review of Media Fills and Research and Development (R&D) batches. Review and approve preliminary batch records after batch record assembly. Review logbooks for accuracy after creation. At any time may be required to perform the job responsibilities for the Documentation Specialist. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent required. Associates or Degree, preferred. Minimum 3 years' experience preferred in QA in a cGMP manufacturing environment. Experience in QA, Compliance, Auditing in a cGMP manufacturing environment is preferred. Demonstrated success in managing multiple activities at the same time and producing outstanding results. Skills in Microsoft Word and Excel are required. Excellent organizational, interpersonal and communication skills (written and oral) required. Strong attention to detail and adherence to Standard Operating Procedures (SOPs). Ability to take feedback constructively and function in a team-oriented work environment. Ability to work overtime as needed. Physical Environment and Requirements Employee must be able to occasionally lift and/or move up to 25 pounds. Expected Hourly Rate: $21.06 - $24.00 The hourly rate displayed is the hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. Our recruiting process includes multiple in person and/or video interviews and assessments. If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

Posted 30+ days ago

W logo

NDE QA Technician / Inspector

Wagstaff, Inc.Spokane, WA

$26 - $35 / hour

Description Wagstaff manufactures equipment for aluminum producers, who process formed aluminum into parts and products you use every day. Pay: $26 - $35 per hour, depending on experience Sign-On Bonus: $5,000 (terms & conditions apply) As an employee of Wagstaff, you'll enjoy: Paid non-working holidays Monthly, site-wide BBQs Up to 8% retirement contribution Annual bonus program 1200 Sqft onsite gym, accessible 24/hrs a day Family-friendly, company-wide events To view our full benefits summary, please visit https://www.wagstaff.com/Wagstaff/Careers.htm Want to learn more about Wagstaff AT? Visit https://www.WagstaffAT.com Job Summary As a Quality Professional on Wagstaff's Quality Assurance team, you will play a crucial role in upholding our reputation for precision and quality. If you are experienced in conducting dimensional, weld and NDE inspections and you are ready to take your career to the next level, join Wagstaff's growing team of Quality Assurance Technicians! In this role, you'll use your experience and skill set to conduct inspections using a variety of precision tools and technologies that have a direct impact on project success at Wagstaff. Your attention to detail and excellent communication skills will contribute to your interactions with co-workers, auditors, customers, suppliers, and visitors, as well as continuous improvement and problem-solving activities. Primary Job Responsibilities Perform weld and NDE (VT/PT/MT/UT) inspections on various stainless steel weldments and fabricated equipement Inspect and report on materials, services, processes, and products using measuring instruments and techniques to ensure conformance with the company's quality standards Enter data and maintain paper and electronic quality records where required Participates in problem solving and continuous improvement projects Represent Wagstaff when interacting with auditors, customers, suppliers and visitors Communicate with customers and suppliers on quality-related issues as directed by the Quality Assurance Manager Prepare inspection sheets Collect, monitor, organize, report, and distribute data as it relates to quality functions of Wagstaff Prepare and present reports Assist with specialized inspections as it correlates with individual certifications. Abide by company policies In order to achieve business objectives, work weeks in excess of 40 hours may be required Other duties as assigned Requirements Candidates must have at least 2 years of dimensional and NDE inspection experience Ability to read blueprints and mechanical inspection skills, experience/training in Geometric Dimensioning and Tolerance (GD&T) Candidates must have vision capable of reading a Jaeger Number 1 or equivalent type and size letter at no less than 12 inches (natural or corrected vision). Candidates cannot be color blind Candidates must be physically able to perform inspections in a manufacturing environment, including the operation of overhead cranes, jibs, and forklifts, after undergoing company training Proficient in the use of Microsoft Office business software Detail-oriented, accurate, and thorough Preferred candidate qualifications: Current AWS Certified Weld Inspector (CWI) with NDE Level II credentials (VT/PT/MT/UT) or the ability to quickly acquire NDE Level II credentials with company-provided training. Experience with AWS D1.1 & 1.6 and ASME Section VIII & B31.3 weld inspections highly desirable. Experience with stainless fabrication highly desirable. Working Environment While performing the duties of this job, work is performed primarily in an adequately lit, well ventilated, climate controlled general office environment. Close computer work is regularly required. The work usually involves minimal physical exertion. The noise level in the general office environment is usually moderate. This job may require occasional or more frequent interaction with employees on the manufacturing shop floor. While on the shop floor, the employee may be exposed to fumes, airborne particles, toxic or caustic chemicals, risks of moving equipment and parts, and other risks associated with a manufacturing environment. Because of this environment and associated risks, coordination with shop floor managers/employees may be necessary before entering the shop floor, and use of job appropriate personal protective equipment and clothing is required on the shop floor. The noise level on the shop floor is often loud. Employment at Wagstaff is dependent on successfully passing a company-paid drug screening and background check upon hire. Benefits eligibility is subject to the terms and conditions of the applicable policies, plans and programs of Wagstaff. Wagstaff is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. PM22

Posted 30+ days ago

Lockheed Martin Corporation logo

QA Engineering Asc Mgr - Grand Prairie, TX

Lockheed Martin CorporationGrand Prairie, TX
Description: You will be the QA Engineering Associate Manager for the GMLRS program team. Our team is responsible for delivering high‑performance precision‑guided munitions that meet the toughest operational requirements. What You Will Be Doing As the QA Engineering Associate Manager you will be responsible for leading quality initiatives across the full program lifecycle-from proposal and contract review through start‑up, production, and sustained support. Your responsibilities will include, but are not limited to: Overseeing all quality activities and ensuring they align with program objectives. Leading a dedicated team to implement and execute program‑specific quality requirements. Ensuring compliance with internal standards, customer specifications, and regulatory mandates. Driving continuous‑improvement initiatives that enhance product reliability and efficiency. Collaborating with engineering, manufacturing, and supply‑chain partners to resolve quality issues quickly. Why Join Us We are looking for a collaborative, results‑driven leader who thrives in a fast‑paced, mission‑critical environment. This role offers the chance to shape quality strategy for a flagship missile program, work with cutting‑edge technology, and make a tangible impact on national security. If you are passionate about excellence and enjoy mentoring high‑performing teams, you will find a home here. We are committed to supporting your work‑life balance and overall well‑being, offering flexible scheduling options. Learn more about Lockheed Martin's comprehensive benefits package here. Further Information About This Opportunity This position is in Dallas. Discover more about our Dallas, Texas location. MUST BE A U.S. CITIZEN - This position is located at a facility that requires special access. The selected candidate must be able to obtain a secret clearance. Basic Qualifications: STEM degree at Bachelor level or higher or equivalent experience/combined education. Quality Engineering Leadership Experience Experience leading bid, proposal and estimating efforts and the development of Quality Assurance Basis of Estimates (BOE) Experience working with metrics and continuous improvement Experience establishing Quality processes and requirements with cross functional, supplier and customer engagement Desired Skills: STEM degree at Bachelor level or higher preferred. CAM training or experience Experience selecting and establishing new suppliers High-rate production experience PF Line of Business Experience/STORM experience Familiarizations with lean initiatives to reduce waste and maintain continuous improvement. Security Clearance Statement: This position requires a government security clearance, you must be a US Citizen for consideration. Clearance Level: Secret Other Important Information You Should Know Expression of Interest: By applying to this job, you are expressing interest in this position and could be considered for other career opportunities where similar skills and requirements have been identified as a match. Should this match be identified you may be contacted for this and future openings. Ability to Work Remotely: Part-time Remote Telework: The employee selected for this position will work part of their work schedule remotely and part of their work schedule at a designated Lockheed Martin facility. The specific weekly schedule will be discussed during the hiring process. Work Schedules: Lockheed Martin supports a variety of alternate work schedules that provide additional flexibility to our employees. Schedules range from standard 40 hours over a five day work week while others may be condensed. These condensed schedules provide employees with additional time away from the office and are in addition to our Paid Time off benefits. Schedule for this Position: 4x10 hour day, 3 days off per week Lockheed Martin is an equal opportunity employer. Qualified candidates will be considered without regard to legally protected characteristics. The application window will close in 90 days; applicants are encouraged to apply within 5 - 30 days of the requisition posting date in order to receive optimal consideration. At Lockheed Martin, we use our passion for purposeful innovation to help keep people safe and solve the world's most complex challenges. Our people are some of the greatest minds in the industry and truly make Lockheed Martin a great place to work. With our employees as our priority, we provide diverse career opportunities designed to propel, develop, and boost agility. Our flexible schedules, competitive pay, and comprehensive benefits enable our employees to live a healthy, fulfilling life at and outside of work. We place an emphasis on empowering our employees by fostering an inclusive environment built upon integrity and corporate responsibility. If this sounds like a culture you connect with, you're invited to apply for this role. Or, if you are unsure whether your experience aligns with the requirements of this position, we encourage you to search on Lockheed Martin Jobs, and apply for roles that align with your qualifications. Experience Level: Experienced Professional Business Unit: MISSILES AND FIRE CONTROL Relocation Available: Possible Career Area: QA/Test and Inspection Type: Full-Time Shift: First

Posted 30+ days ago

Vertex Pharmaceuticals, Inc logo

Associate Director, GMP Operational Quality (QA Ops For QC)

Vertex Pharmaceuticals, IncBoston, MA

$156,600 - $234,800 / year

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Overview

Schedule
Full-time
Career level
Director
Remote
On-site
Compensation
$156,600-$234,800/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance

Job Description

Job Description

General Summary:

The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. The role will also oversee team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams.

This role requires collaborative interaction with cross-functional partners such as analytical and process development, clinical and commercial QC, and manufacturing operations to ensure the on-time closure of deviations, CA/PA, and change controls. This QA position will work with internal and external QA teams and QC labs ensuring adherence to compliance while supporting both clinical and commercial release and stability testing of a genetically edited cell therapy product. The position will provide compliance support to both clinical and commercial data review and data management.

This person will support QA activities related to GMP release and stability as well as lifecycle improvement for methods related to raw material, in-process, and drug product samples. The GMP-facing nature of this work requires keen attention to detail and understanding of analytical compliance expectations.

Key Duties and Responsibilities:

  • Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex
  • Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
  • Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms
  • Enable team to achieve team goals/objectives and enable their individual career development
  • Develop and maintain compliant quality processes to support GMP activities
  • Oversee the QA support of Change Controls, GMP investigations and associated CAPAs.
  • Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes
  • Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.
  • Support review of regulatory submissions, as applicable
  • Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
  • Lead and follow up on any QLT action items assigned.
  • Identify and communicate risks and assist with risk mitigation plans as necessary
  • Supports internal audit or external audit programs; assists in preparation of audit responses
  • Provide comprehensive knowledge support for partner and regulatory agency audits
  • Assist management team in budgeting and scheduling
  • Responsible for the following activities related to people management responsibilities:
  • Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding
  • Performance Management (goals, monitoring, reviews);
  • Monitoring /Supporting Employee Engagement and Retention;
  • Succession Planning;
  • Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs.
  • Accountable to provide oversight of day to day team operations
  • Assists with workforce planning/resource modeling and to update through forecasting activities

Knowledge and Skills:

  • In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing
  • Demonstrated success in building high-performing teams and skilled at managing team and individual development
  • Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness
  • Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
  • Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit
  • Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development
  • Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action
  • Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions
  • Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
  • Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
  • Supstantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)

Education and Experience:

  • Seven (7) + years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in cGMP related industry, with four (4) or more years of work experience in proven leadership/supervision and experience within a sterile manufacturing site and sterilization activities.

Preferred Master's degree or relevant comparable background.

Required Experience

  • Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.)

  • Knowledge of standard microbiological procedures (sterility testing, environmental monitoring, bioburden, and bacterial endotoxin testing)

  • Must have experience in ethylene oxide, steam sterilization, and gamma radiation requirements. #LI-onsite

Pay Range:

$156,600 - $234,800

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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