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INCOG BioPharmaFishers, IN
QA Aseptic Principal Job Summary Join our dynamic Quality Assurance team as a senior technical leader who will shape the future of aseptic manufacturing excellence at INCOG! This is an exceptional opportunity for an experienced QA professional to become the subject matter expert on aseptic processes, contamination control, and regulatory compliance in a fast-growing CDMO environment. You'll work alongside a collaborative team of quality professionals who are passionate about ensuring patient safety while supporting our clients' success in bringing life-saving therapies to market. As the QA Aseptic Principal, you will serve as the technical authority for all aseptic manufacturing operations, providing critical oversight of media fills, isolator setups, and contamination control strategies. This senior individual contributor role combines hands-on technical expertise with strategic leadership, as you guide training initiatives, represent our systems to regulatory agencies and clients, and ensure our aseptic controls stay ahead of evolving FDA and EMA expectations. You'll have direct impact on product quality and patient safety while helping establish INCOG as the premier CDMO for sterile injectable manufacturing. Essential Job Functions: Aseptic Process Oversight: Provide quality assurance oversight and approval for all media fills, aseptic setup procedures for isolators, and aseptic process validations to ensure compliance with cGMP requirements; develop and improvesystem reporting document and system improvements to support multi-product, multi-client manufacturing operations Contamination Control Leadership: Develop, implement, and maintain comprehensive contamination control strategies using risk-based methodology across sterile manufacturing operations. Lead multi-functional risk assessment and other technical exercises to assess and improve aseptic conditions and operations. Environmental Monitoring Program Management: Review and approve quarterly environmental monitoring reports, trend analysis, and investigation of excursions to ensure continuous improvement of aseptic conditions Aseptic Intervention Guidance: Serve as the technical authority for evaluating and approving aseptic interventions, including risk assessments, corrective actions, and impact evaluations on product sterility assurance Training and Development: Design and deliver comprehensive training programs for manufacturing floor personnel and QA staff on aseptic technique, contamination control principles, and regulatory requirements; assess on-the-floor trainers' expertise and support the training and assessments of floor operations and operators Subject Matter Expertise: Function as the primary SME on aseptic manufacturing risks, providing technical guidance on complex sterility assurance challenges and emerging regulatory trends Regulatory and Client Interface: Represent INCOG's aseptic systems and controls during FDA, EMA, and client audits, providing technical presentations and responding to regulatory inquiries. Serve as the primary respondent to client and regulatory audits for aseptic topics. Regulatory Compliance Assurance: Ensure all aseptic controls and contamination control measures meet current FDA, EMA, ICH, and other applicable guidance documents and regulations Proactive Regulatory Intelligence: Monitor and analyze FDA and EMA observations, warning letters, and guidance updates to implement preventive measures and maintain competitive regulatory positioning Special Job Requirements: Bachelor's degree in Microbiology, Biology, Chemistry, Chemical Engineering, or related scientific discipline Minimum 10 years of experience in pharmaceutical manufacturing with at least 8 years focused on aseptic manufacturing and sterile drug product operations Minimum 7 years of Quality Assurance experience with media fills, environmental monitoring programs, and contamination control in a cGMP environment; proven technical leadership through FDA responses and new product introduction Previous experience as a subject matter expert or technical lead in aseptic operations Demonstrated experience with FDA and/or EMA inspections and regulatory interactions Experience with client audits and technical presentations to external stakeholders Demonstrated experience in aseptic operations optimization and improvements, including Annex 1 remediations and ensuring Strong knowledge of USP , FDA Guidance for Industry on Sterile Drug Products, and EU GMP Annex 1 Experience with isolator technology, RABS (Restricted Access Barrier Systems), and aseptic fill-finish operations Proven track record in training development and delivery for technical topics Excellent written and verbal communication skills with ability to present to senior management, clients, and regulatory agencies 3-5 years of experience in CDMO or contract manufacturing environment supporting multiple clients and diverse product portfolios Additional Preferences: Advanced degree (MS/PhD) in relevant scientific discipline Professional certifications such as ASQ CQE, CQA, or equivalent quality certifications Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 30+ days ago

Broadcom Corporation logo
Broadcom CorporationPlano, TX

$108,000 - $172,800 / 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: Senior Linux QA Engineer Job Description: Are you a passionate IT professional ensuring top-notch software quality and driving innovation? We are seeking a dynamic Senior Linux QA Engineer to join our R&D team. In this pivotal role, you will be responsible for formulating a robust QA strategy, enhancing code coverage, collaborating with product QAs, and leading initiatives to elevate engineering excellence. If you thrive in a fast-paced Agile environment and have a passion for continuous improvement, this role is tailor-made for you! Key Responsibilities: QA Strategy Architect: Develop and execute a comprehensive QA strategy that aligns with our product vision and business goals. Demonstrate and cultivate a passion for delivering high-quality products aligned with customer needs. Collaborate with cross-functional teams to define quality standards, best practices, and testing methodologies. Identify areas for process improvement; drive initiatives to enhance QA efficiency and effectiveness. Code Coverage Enhancement: Analyze source code to identify gaps in test coverage and increase coverage in product features and modules that may be prone to defects. Champion the adoption of code coverage tools and techniques to ensure thorough testing. Collaboration and Leadership: Collaborate with other product QAs to share knowledge, best practices, and lessons learned. Continue to build Linux expertise and keep abreast of new technology, processes, systems, and tools. Lead by example, fostering a culture of quality and continuous learning within the QA team. Mentor junior engineers and guide them in their professional growth. CI/CD Pipeline Champion: Drive the establishment and optimization of robust CI/CD pipelines. Advocate for a test-first approach, ensuring that automated tests are integral to the development process. Collaborate with internal and central engineering teams to streamline our testing, packaging, and building process to streamline our testing and minimize time-to-market in getting out product fixes (APARs). Engineering Excellence Initiatives: Take the lead in engineering excellence initiatives, promoting best practices, code quality, and technical debt reduction. Encourage innovation and experimentation within the QA team. Contribute to retrospectives and actively address impediments to team productivity. Agile Backlog Refinement and Planning: Work as part of a self-directed Agile team, taking ownership of assigned work and sharing accountability for delivering high quality results. Collaborate with Product Management during backlog refinement sessions. Estimate features, identify risks, and contribute to achievable Program Increment (PI) objectives. Foster cross-team coordination by identifying dependencies and capturing local backlog items. Actively participate in team planning and contributing to team goals. Volunteer for and commit to delivering stories and tasks within the sprint. Required Skills & Competencies: Experience with Linux systems, preferably one or both x86 and s390x architectures. Linux security, OpenSSL, and certificate management. Knowledge of performing security scans using tools like Blackduck and Coverity. Knowledge and related product expertise in CI/CD methodologies using automation tools like Ansible, Jenkins, Python, Git, Groovy, Artifactory, etc. Knowledge of Cloud technologies especially around Cloud Storage (on or off z/OS) is a plus. Desired Technical Skills & Experience Experience with OpenShift, Kubernetes, Docker or Podman, and tools related to automating the deployment and management of containerized applications. Linux performance monitoring and tools. An understanding of Linux Hardware and virtual machine configurations using hypervisors. Additional experience in one or more of the following open systems languages: JAVA, C, Metal C, and Python. Open to learning new technologies and languages, following new trends, and continuous innovation. Build great user interfaces and experiences with our in-house component library, used by all Broadcom's Mainframe software products, is a plus. Preferred Education: Bachelor's degree or global equivalent in a related field. Work Experience: Preferably, eight (8) or more years of experience in software development or a related field with various Linux distributions, architectures system internals, and utilities. Business Travel and Physical Demands: No (or minimal) business travel is expected for this position. Office environment. No special physical demands are required. Additional Job Description: Compensation and Benefits The annual base salary range for this position is $108,000 - $172,800 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

Simmons Bank logo
Simmons BankLittle Rock, AR
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. Compliance Specialist II works directly with a Compliance Manager to meet the requirements of the assigned regulatory area of the Compliance Management Program which includes researching, reviewing, and interpreting existing and pending laws and regulations. The Compliance Specialist II provides assistance to management in order to maintain a quality compliant culture. Essential Duties and Responsibilities Researches, reviews, and interprets existing and pending laws and regulations, which potentially affect the assigned regulatory area, such as CRA, HMDA, etc. Assists the compliance manager in establishing and modifying standards, policies, and procedures which affect compliance. Works directly with the Compliance Manager to meet the requirements of the Compliance Management Program, which includes associate training, conducting internal assessments, and board reports. Provides ongoing assistance and support to the compliance manager in administrative responsibilities. Assists management in new product development, systems, and procedures. Provides input relative to compliance and regulatory matters. Ensures that all departmental documents and activities are performed in compliance with applicable laws, regulations, policies and procedures as applicable to this position, including completion of required compliance training. Performs other duties and responsibilities as assigned. 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. Skills Ability to read and comprehend simple instructions, short correspondence and memos. Ability to read and interpret documents such as procedure manuals, general business correspondence and/or journals or government regulations. Ability to read, analyze and interpret financial report and/or legal documents. Ability to write simple-to-business correspondence, routine reports, and procedures. Ability to respond in writing to customer complaints, regulatory agencies or members of the business community. Education and/or Experience BS/BA Degree (4 year) from an accredited university /college or two to four years' experience in equivalent compliance position, preferred. CRCM certificate or three years of experience in compliance assessment s plus knowledge of CRA and Fair Lending regulations, preferred. Computer Skills MS Word, Excel, PowerPoint, and Outlook Other Qualifications (including physical requirements) Must have good time management, communication, and organizational skills. Equal Employment Opportunity Information: Simmons First National Corporation and its subsidiaries are committed to a policy of equal employment with respect to a person's race, color, religion, sex, ancestry, sexual orientation, gender identity, national origin, covered veterans, military status, physical or mental disability or any other legally protected classifications.

Posted 30+ days ago

SS&C Technologies logo
SS&C TechnologiesNew York, NY

$80,000 - $100,000 / year

As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale, and technology. Job Description Job Title: QA Automation Engineer Locations: NYC | Hybrid 6x a month (Hiring Locally Only) Get To Know Us: SS&C Innovest seeks a Quality Assurance Automation Engineer to join its quality assurance team. With offices in New York, Texas and California, SS&C Innovest specializes in trust, wealth management, payments, unique and hard‐to‐value assets, securities operations, and information systems. For our current opening we are looking for an experienced Quality Assurance Engineer with excellent analytical and communication skills. S/he will join our Quality Assurance team, leading efforts to innovate, collaborate, and execute with a sense of urgency (without sacrifice to quality). Why You Will Love It Here! Flexibility: Hybrid Work Model and Business Casual Dress Code, including jeans Your Future: 401k Matching Program, Professional Development Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Sick Leave, Paid Holidays Your Wellbeing: Medical, Dental, Vision, Employee Assistance Program, Parental Leave Wide Ranging Perspectives: Committed to Celebrating the Variety of Backgrounds, Talents and Experiences of Our Employees Training: Hands-On, Team-Customized, including SS&C University Extra Perks: Discounts on fitness clubs, travel and more! What You Will Get To Do: Develop effective QA processes and procedural documents, and maintain changes accordingly Design and implement scalable test automation frameworks and tools Develop automated UI, API, and integration tests Maintain test environments and manage test data Create comprehensive test plans and cases Execute automated regression testing and bug tracking Collaborate with development teams on unit testing and quality gates Track and report on test coverage metrics Participate in Agile Agile/Scrum and daily stand-ups Identify and implement test framework improvements Document testing processes and best practices Mentor QA team What You Will Bring: Bachelor's Degree from an accredited institution 3+ years' experience developing test automation frameworks and scripts using Python, Java, or JavaScript Strong expertise with Selenium WebDriver and other DDT and BDD frameworks (TestNG, JUnit, Cucumber) Experience with Git version control and cross-browser testing Proficiency in SQL and test data management Experience with REST/SOAP APIs and API testing frameworks Strong background in test reporting, metrics, and continuous testing practices Track record of meeting aggressive deadlines while maintaining quality standards Extensive knowledge in software testing methodology and software development lifecycle Familiarity with relational database navigation (SQL queries, etc.) Proficiency in writing test cases and test plans based on business requirement specifications MUST HAVE a proven track record of exceptional ambition, drive, and proven results. In college and/or professionally Excellent verbal and written skills What will set you apart from the pack? Experience in investment management or financial technology Experience with CI/CD tools (Jenkins, GitLab) Familiarity with low-code automation tools (Katalon, TestComplete) Banking/finance domain knowledge Thank you for your interest in SS&C! If applicable, to further explore this opportunity, please apply directly with us through our Careers page on our corporate website: www.ssctech.com/careers. #LI-BP1 #CA-BP Unless explicitly requested or approached by SS&C Technologies, Inc. or any of its affiliated companies, the company will not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. SS&C offers excellent benefits including health, dental, 401k plan, tuition and professional development reimbursement plan. SS&C Technologies is an Equal Employment Opportunity employer and does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws. Salary is determined by various factors including, but not limited to, relevant work experience, job related knowledge, skills, abilities, business needs, and geographic regions. NY: Salary range for the position: 80000 USD to 100000 USD.

Posted 2 weeks ago

Blitt & Gaines P.C. logo
Blitt & Gaines P.C.Kansas City, MO
Description Job Title: Software QA Analyst Job Summary: We are seeking a motivated and detail-oriented Software Quality Assurance Analyst to join our development team. The ideal candidate has a strong understanding of QA fundamentals, experience translating requirements into effective test coverage, and a willingness to learn and grow within a fast-paced software environment. You will work closely with product owners, developers, and other team members to ensure the delivery of high-quality software solutions. This is an experienced level position. You will report to the Director of Development and work to test a variety of applications and processes for our firm. Key Responsibilities: Review acceptance criteria and requirements to create comprehensive, well-structured test cases. Execute manual and/or automated tests across various applications and environments. Perform comparisons and validations of large datasets to ensure accuracy and data integrity. Assist with the setup, configuration, and maintenance of applications within test environments. Document test results, defects, and reproducible steps using standard ALM tools (e.g., Azure DevOps, Jira). Collaborate with developers and product owners to clarify requirements and ensure alignment with SDLC processes. Participate in test planning, requirement reviews, and release readiness activities. Minimum Requirements: 1+ years of experience in a manual or automated QA role. Demonstrated ability to create test cases from acceptance criteria or requirements. Solid understanding of Software Development Lifecycle (SDLC) concepts. Familiarity with ALM or defect-tracking tools such as Azure DevOps, Jira or similar. Experience comparing and analyzing large datasets using tools such as Microsoft Excel, SQL, or similar technologies. Experience with application setup and configuration within test environments. Preferred Qualifications: Proficiency with Azure DevOps for managing test plans, executing test cases, tracking defects, and collaborating across development teams. Experience using Visual Studio to execute tests, debug issues, analyze logs, and support development workflows. Hands-on experience testing Python applications, including working with virtual environments, dependency management, and common testing tools (e.g., pytest, unittest). Ability to write or maintain automated tests using recognized testing frameworks such as Selenium, Playwright, pytest, NUnit, or xUnit, depending on application stack. Familiarity with version control systems such as Git, including branching strategies and review workflows. Nice to Haves: Experience with QA automation, including scripting or working with testing frameworks such as Selenium, Playwright, NUnit, xUnit, or similar. Exposure to CI/CD pipelines and their role in QA processes. Familiarity with the litigation and/or collections industry, including common workflows and data structures. Exposure to scripting or automation tools (e.g., Python, PowerShell, Bash) Benefits: Blitt and Gaines, P.C. offers PTO, Paid Holidays, Medical Benefits, Competitive Salary and 401k and profit sharing plans! Medical Benefits include - Medical, Dental, Vision, Life Insurance and Short Term Disability.

Posted 3 weeks ago

Wolters Kluwer logo
Wolters KluwerClayton, MO
Wolters Kluwer's ftwilliam.com platform empowers professionals to streamline Defined Benefit (DB) plan compliance testing, valuation, and proposal generation. As an Industry Solutions Consultant- DB Compliance QA, you'll play a critical role in ensuring our solutions meet the highest standards of accuracy and functionality. In this position, you'll leverage your expertise in ERISA regulations and plan design-covering DB plans, DB/DC combo plans, and cash balance plans-to influence feature design and perform rigorous testing. Working within an agile team, you'll help deliver enhancements that make a real impact for our customers, ensuring every release is reliable, compliant, and user-focused. You will report to the Manager, Consulting- Industry Solutions and work a hybrid schedule (2 days in office, 3 days from home) from one of our local offices. Responsibilities: Collaborate with the product owner and development team to refine user stories before development begins Create sample plans, expected results, and acceptance criteria for new features Perform comprehensive testing of new features and document all tests conducted, including manual and automated tests Ensure software functionality aligns with ERISA laws and regulations Stay current with ERISA laws, regulations, and industry standards Maintain detailed documentation for future testing of similar features and enhancements Identify and suggest software improvements during the testing process Keep up to date with best practices in testing methodologies and tools Work closely with other Industry Solutions Consultants to develop consistent testing policies and procedures Qualifications: ASPPA Credential, such as QPA, or NIPA Credential At least 3 years of experience working with peer review in retirement services 1 years of experience working in a development QA environment Experience with customer support is a plus Familiarity with various project management and workflow tools Experience with ftwilliam.com DB Compliance software is a plus Detail oriented Quick learner and self-starter Ability to multi-task Ability to work well in a team Ability to perform well under pressure Ability to perform well with minimal supervision #LI-Hybrid Benefits: A comprehensive benefits package that begins your first day of employment. Additional Information: Wolters Kluwer offers great benefits and programs to help meet your needs and balance your work and personal life, including Medical, Dental, & Vision Plans, 401(k), FSA/HSA, Commuter Benefits, Tuition Assistance Plan, Vacation and Sick Time, and Paid Parental Leave. Full details of our benefits are available - https://www.mywolterskluwerbenefits.com/index.html Diversity Matters: Wolters Kluwer strives for an inclusive company culture in which we attract, develop, and retain diverse talent to achieve our strategy. As a global company, having a diverse workforce is of the utmost importance. We've been recognized by employees as a European Diversity Leader in the Financial Times, as one of Forbes America's Best Employers for Diversity in 2022, 2021 and 2020 and as one of Forbes America's Best Employers for Women in 2021, 2020, 2019 and 2018. In 2020, we placed third in the Female Board Index, and were recognized by the European Women on Boards Gender Diversity Index. Wolters Kluwer and all of our subsidiaries, divisions and customer/departments is an Equal Opportunity / Affirmative Action employer. Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process.

Posted 2 weeks ago

Farmer Focus logo
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 3 weeks ago

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Perrigo Company CorporateAllegan, MI
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 As a Quality Assurance Engineer, you will support and participate in continuous improvement activities in the operations areas. This person will provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMI and ensures that all information and documentation conforms to company policy, cGMP's and all other applicable FDA guidance's. Please note: This role is currently structured as 4 days onsite, 1 day remote. Scope of the Role Leads/Participates in quality driven initiatives in the continuous support of Quality improvements, using data analysis techniques and other improvement tools. Responsible for reviewing and approving documents such as deviations, Annual product reports, non-routine batch status change requests, planned deviations, calibration non conformances, etc. Provides initial risk assessment of Quality events. Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality. Experience Required Bachelor's Degree in a scientific discipline or closely aligned field, with a minimum of two years experience working in an FDA regulated industry, preferred. Demonstrated understanding and application of Continuous Improvement and Root Cause analysis skills. Demonstrated understanding of and ability to apply cGMPs and US FDA laws and requirements in an FDA regulated industry. Strong functional knowledge of SAP systems. Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines. 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. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. 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: Grand Rapids

Posted 2 weeks ago

PwC logo
PwCMinneapolis, MN
Industry/Sector Not Applicable Specialism Managed Services Management Level Manager Job Description & Summary At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively. As a risk management generalist at PwC, you will provide advisory and practical support to teams across a wide range of specialist risk and compliance areas. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Analyse and identify the linkages and interactions between the component parts of an entire system. Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion. Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables. Develop skills outside your comfort zone, and encourage others to do the same. Effectively mentor others. Use the review of work as an opportunity to deepen the expertise of team members. Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate. Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements. Minimum Degree Required Bachelor's Degree Minimum Year(s) of Experience 5 year(s) Demonstrates extensive knowledge and/or a proven record of success in the following areas: Quickly and agilely learn client HCP and HCO engagement processes and ways of working, analyzing for opportunities to optimize, develop, update, and govern team playbooks, SOPs, and process documentation to ensure operational consistency and compliance; Develop and maintain training plans for both new and existing team members; Designing and delivering training curricula for new hires and ongoing development for existing team members; Keeping training materials current with process changes, client requirements, and industry/regulatory updates; Managing and delivering structured onboarding programs for new hires to ensure smooth integration and readiness; Providing coaching and skills development opportunities to build functional expertise across the team; Partnering with leadership to identify training gaps and address them proactively; Designing and executing quality monitoring frameworks to evaluate managed services team delivery accuracy, compliance, and timeliness of deliverables; Conducting regular quality reviews of outputs (e.g., tiering assessments, contracting, payment processing); Tracking and reporting quality performance metrics; identify root causes of recurring errors and define corrective actions; Partnering with leadership to implement corrective training and process refinements; Leading process improvement and optimization; Serving as a key SME in continuous improvement initiatives, contributing to best practices across global operations; Mentoring junior team members; Supporting the process design and implementation of new client or new markets ensuring a high-level of customer engagement, quality, timeliness, and service-readiness across all regions; Managing deliverables on or ahead of deadlines and reporting any issues/risks beforehand; Experience in life science meetings & events, pharmaceutical device or healthcare setting working with HCPs, HCOs or Patients; Identifying opportunities for efficiency, automation, and standardization within the managed services delivery model; Working closely with the client-dedicated operations team to streamline processes while maintaining quality and compliance; Communicating with senior leadership and senior client stakeholders; Delivering "white glove" customer service; Ability to work in a fast-paced environment, with a strong emphasis on quality and accuracy; Monitoring and managing other responsibilities not necessarily listed but logically inherent to the role; Leading teams of individuals with a positive attitude; Strong English language reading comprehension and writing skills. Travel Requirements Up to 40% Job Posting End Date Learn more about how we work: https://pwc.to/how-we-work PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy . As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines The salary range for this position is: $99,000 - $232,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance

Posted 2 weeks ago

Seek Now logo
Seek NowAtlanta, GA
Why Join Us? We're a high-growth, profitable tech company reshaping how the insurance industry handles property claims. While this space isn't known for being "high-tech," we're changing that narrative-building solutions that were once thought impossible. As a Quality Engineer, you'll play a pivotal role in ensuring our products not only work flawlessly but set the gold standard for reliability in the industry. What You'll Do Design & Lead- Build evolving test strategies for new features and functionality, ensuring quality is baked in from day one. Engineer Confidence- Develop and maintain a robust library of test approaches across web and mobile, so our teams can move fast without breaking things. Test Smart- Execute both manual and automated testing, leveraging the right tools to keep our suite resilient. Be the Product Expert- Dive deep into our offerings, collaborate with Product Support & Development, and track down root causes with precision. Raise the Bar- Champion quality practices across engineering, helping teammates ship with confidence. What You Bring QA Mindset- A strong grasp of modern testing methodologies, test design thinking, and the art of finding what others might miss. Web & Mobile Expertise- Hands-on experience testing modern web apps and hybrid mobile applications. Collaborator at Heart- You thrive on helping engineers succeed, quickly analyzing and fixing issues when things inevitably break. Problem-Solver- Strong critical thinking and troubleshooting skills that cut through complexity. Bonus Points If You Have Experience automating tests for front-end, back-end, or mobile apps using tools like Selenium, Cypress, Postman, Playwright, or others you've wielded successfully. Why You'll Love It Here Impact from Day One- Your work ensures our products deliver on the promise of reliability in a space that desperately needs it. Fast Growth, Big Opportunities- As we scale, so do your opportunities-whether it's leadership, specialization, or new tech domains. Collaborative Culture- Work with smart, humble teammates who prioritize results over ego. Autonomy & Trust- We give you the freedom to solve problems your way. EEO Statement: Seek Now is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. Seek Now does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Posted 30+ days ago

Arthrex, Inc. logo
Arthrex, Inc.Santa Barbara, CA

$103,951 - $175,350 / year

Requisition ID: 64489 Title: Software QA Engineer II -Automation Division: Arthrex, Inc. (US01) Location: Santa Barbara, CA Salary Range: Salary Minimum: $103,951.00 Salary Maximum: $175,350.00 Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Software QA Engineer II-Automation who works directly with the Engineering departments within Arthrex with good critical thinking skills who is eager to learn new technologies. This role will support our Arthrex California Technology teams. The Software Quality Engineer tests and performs quality analysis of application functionality to ensure that Arthrex business systems meet user requirements, work as intended, and are within quality management limits and standards. Excellent communications and analytical skills, strong technical project management skills will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better. This position is onsite located at our Santa Barbara location. Essential Duties and Responsibilities: Support complex release projects including various testing activities - test planning; project estimation and scheduling; resource planning, training, and oversight; test development; test execution; defect management; daily/weekly status reporting; and project closure. Apply test methodology, define test strategy and types of testing to be performed, and ensure comprehensive testing is performed on the project to assure the quality of an application's usability, functionality, security, and performance. Ensure Arthrex SQA standards and processes are followed. Responsible for the entire testing project. Perform testing assignments including integrations with other systems, performance testing if needed, and migration of data from one database or system to another in large implementation or major release projects. Work with infrastructure and application development teams to establish and maintain test environments. Communicate issues identified during testing activities to application development team lead and manager, assist in the triage and resolution, advise on design/architectural solutions, and recommend process/application improvements to management. Represent SQA on application/project teams and in software development, project planning, and requirement gathering meetings. Attend project status meetings and provide SQA status, work with PM to define SQA tasks and estimates for the project schedule. Complete SQA tasks and meet deadlines, for individual or multiple projects. Contribute to SQA metrics such as requirements coverage, test case readiness, test execution progress, and defect counts and statistics in SQA test management tool. Automate test cases using the automated testing framework that is built in C#. Add automated test cases to the nightly automation run. Ensure test cases are passing daily and log bugs when necessary if failed. Knowledge Intermediate level testing skills and possesses partial to full knowledge of assigned Arthrex business systems. Understands how to develop test cases, automated scripts, test plan documentation, and test summary reports. Reasoning Ability Ability to define problems, collect data, establish facts, and draw valid conclusions. Can solve routine problems of limited scope and complexity following established policies and procedures. Education/Experience High School diploma or equivalent required. Bachelor's Degree in Computer Science or related field preferred. 2 years relevant work experience. Skills Working knowledge of the Software Development Life cycle and SQA's role in it through proven explanation of the process. Solid understanding of programming languages and several technologies including relational databases, SQL and XML/JSON, C#, Python, Mongo DB a plus. Experience with Selenium, Appium, Jenkins. Demonstrated ability to document test plans, test cases, test results. Experience with Jira, Zephyr or any test management system and Agile practice. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Gym Reimbursement Program Tuition Reimbursement Program Trip of a Lifetime Paid Parental Leave Paid Time Off Volunteer PTO Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Making People Better at Arthrex Lorem ipsum dolor sit amet consectetur. Cras fringilla elementum odio velit. Job Details Date: Dec 4, 2025 Requisition ID: 64489 Salary Range: Job title: Software QA Engineer II -Automation Arthrex Location: Santa Barbara, CA, US, 93111 Nearest Major Market: Santa Barbara Nearest Secondary Market: Santa Maria Job Segment: Testing, Application Developer, QA, Quality Manager, QA Engineer, Technology, Quality, Engineering

Posted 3 weeks ago

Thermo Fisher Scientific logo
Thermo Fisher ScientificGreenville, North Carolina
Work Schedule 12 hr shift/nights Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com . GROUP/DIVISION SUMMARY The Drug Product Division- North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. POSITION SUMMARY In this position, you’ll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours are 6p- 6a, on a 2-2-3 rotation. Key Responsibilities: Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs. Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique Champions quality culture by aiding personnel in understanding application of policies and controls Participates in RAPID event response and provides quality guidance for deviation events Advances deviation events to the appropriate area and quality management Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity Performs quality review and approval of deviation and change control of moderate to high complexity Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity Performs quality batch record review Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives Qualifications: Bachelor’s degree, preferably in technology, engineering or microbiology related field required. 5+ years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing required Previous experience in pharmaceutical industry, preferably with QA oversight experience within an aseptic or steriles filling and manufacturing operation strongly preferred. Experience in other GMP environments may be considered (i.e. ISO 9001) An equivalent combination of education and relevant experience may be considered. Ability to capture data, analyze & troubleshoot process issues, equipment problems along with production leadership Ability to troubleshoot process and equipment issues Hard-working, demonstrated ownership & responsibility; Ability to lead, support & empower a team/peers Technical Writing experience Professional certifications (ex: CQA) and training (Six Sigma) are a plus Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally. Benefits: We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Posted 6 days ago

Morgan Stanley logo
Morgan StanleyAlpharetta, Georgia
Job Title: Lead QA Engineer, Director, P4 Location: Alpharetta, GA Department: Wealth Management and Investment Management Technology (WMIMT) Department profile: Morgan Stanley Wealth Management (MSWM) Technology is the global technology department responsible for the design, development, delivery and support of the technical solutions behind the products and services used by the Morgan Stanley Wealth Management (MSWM) business.Wealth Management Technology is responsible for the design, development, delivery, and support of the technical solutions behind the products and services used by the Morgan Stanley Wealth Management Business. Practice areas include: Analytics, Intelligence, & Data Technology (AIDT), Contact Center, Client Platforms, Core Technology Services (CTS), Financial Advisor Platforms, Global Banking Technology (GBT), Investment Solutions Technology (IST), Institutional Wealth and Corporate Solutions Technology (IWCST), Technology Delivery Management (TDM), User Experience (UX), and the CAO teamQuality Assurance Center of Enablement (QA COE) partners with Wealth Management development teams and partner technology organizations to enable the delivery of technology solutions to our business in the most efficient, predictable manner possible. What you’ll do in the role: We are seeking for a QA automation expert who can work across different fleets for critical initiatives such as ETrade Integrations, Parametrics , Account Inception tool amongst others. Lead testing initiatives for Mavericks and Panthers squads. Collaborate with dependent and consumer teams outside of the Advisory Fleet. Establish and execute an automation strategy for regression coverage. Ensure production stability for products without dedicated squads. Convert manual test cases into automated tests for repeatable and reliable coverage. Work on reducing the need for multiple consultants and shortening execution timelines. What you’ll bring to the role: Extensive experience of 5 years or higher in Wealth Management/Investment Banking. Deep understanding of software testing methods ¶digms and ability to draw up test strategies and test plans. Experience with managing Functional and Regression testing for large products over multiple releases. Experience with planning and executing one or more non-functional requirement. Hands-on experience in writing and executing test scenarios, test cases or automation scripts. Hands on automation expertise in UI and API automation using Java. Should have experience in Selenium, RestAssured and other Automation tools. Ability to operate in a CI / CD-enabled environment, Git, Jenkins and contribute to the CI / CD pipeline. Test management tools - JIRA or any other test management tool. Hands-on experience in defect logging, tracking, and verifying defects. Experienced in driving work in a fast-paced agile environment. Good understanding of large and complex solutions / architecture Strong interpersonal, facilitation, and leadership skills along with effective communication (both written and verbal) skills and the ability to present complex ideas in a clear, concise way to the team as well as Management. Engage in a highly collaborative team environment including business partners and product owners. Education: Bachelor's/Master's Degree in Engineering, preferably Computer Science/Engineering WHAT YOU CAN EXPECT FROM MORGAN STANLEY: We are committed to maintaining the first-class service and high standard of excellence that have defined Morgan Stanley for over 89 years. Our values - putting clients first, doing the right thing, leading with exceptional ideas, committing to diversity and inclusion, and giving back - aren’t just beliefs, they guide the decisions we make every day to do what's best for our clients, communities and more than 80,000 employees in 1,200 offices across 42 countries. At Morgan Stanley, you’ll find an opportunity to work alongside the best and the brightest, in an environment where you are supported and empowered. Our teams are relentless collaborators and creative thinkers, fueled by their diverse backgrounds and experiences. We are proud to support our employees and their families at every point along their work-life journey, offering some of the most attractive and comprehensive employee benefits and perks in the industry. There’s also ample opportunity to move about the business for those who show passion and grit in their work. To learn more about our offices across the globe, please copy and paste https://www.morganstanley.com/about-us/global-offices​ into your browser. Morgan Stanley's goal is to build and maintain a workforce that is diverse in experience and background but uniform in reflecting our standards of integrity and excellence. Consequently, our recruiting efforts reflect our desire to attract and retain the best and brightest from all talent pools. We want to be the first choice for prospective employees. It is the policy of the Firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, sex stereotype, gender, gender identity or expression, transgender, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy, veteran or military service status, genetic information, or any other characteristic protected by law. Morgan Stanley is an equal opportunity employer committed to diversifying its workforce (M/F/Disability/Vet).

Posted 2 weeks ago

Tutor Perini logo
Tutor PeriniBrooklyn, New York

$160,000 - $220,000 / year

The salary range for this position is between $160,000 and $220,000 depending on experience Tutor Perini O&G Joint Venture is the company selected to execute construction of the Manhattan Jail Project in New York. Tutor Perini O&G JV is seeking a QA/QC Manager to join the project in Manhattan, NY About Manhattan Jail Project Extraordinary Projects, Exceptional Performance The $3.8B project scope includes design and construction of a new state-of-the-art facility that will have dedicated space for on-site services and programming, indoor and outdoor recreation, food services, staff offices and facilities, amenities, below-grade accessory parking, and a secured entry. The new facility will contain 1,040 beds and provide 125 accessory parking spaces below grade for all staff and service providers. In addition, the facility will provide 20,000 square feet of community and commercial space on the ground floor. Extraordinary Projects need Exceptional Talent Job Description: Developing and revising Quality Management Plan, based on lesson learned and improve the Quality Management Process An overall review of incoming inspections, in-process inspections, final inspections, and calibration records, and training Responsible for internal/external auditing (construction entities, and other subcontractors Schedule and provide training for Preparation Phase training The QA for all inspection and test activities and attend and verify tests and inspections required to ensure material compliance with the plans and specifications Contract Document requirements execution and oversight Perform quality oversight on all subcontractors by reviewing Subcontractor Quality Management Plan/Quality Control Plan and reviewing agreements with subconsultants Monitor subconsultant performance and compliance with the Contract Ensure adequate resources (QC Team) are available for the project General QC administration QC staffing and supervision Coordinate QC testing with QC subconsultant such as Material Testing Lab and Commissioning Agent/System Integrator. Provide recommendation and communication with DOR for problem solution and verification of corrective actions. Develop and implement corrective measures in cases of noncompliance. Verify corrective action(s) Maintain QC records in accordance with QMP Ensure and verify the Subcontractors perform inspection for all construction materials to be used at the site to ensure compliance with material approvals Responsible for the strict adherence to company safety policies and programs Perform primary quality assurance/quality control inspections required in conformance with the project contract drawing and specifications Attend all jobsites and prepare documentation for Quality Meetings Required Skills: Bachelors Degree in Engineering, Construction Management, Business Management or similar, from an accredited institution 10 or more years of experience in support heavy civil construction testing, inspection, supervision or management in support of large public works projects Five (5) or more years as a Supervisor or Manager of construction quality control teams Experience with contract specifications as they apply to quality control teams Experience with MS Office Excellent written and verbal skills Equal Opportunity Employer

Posted 30+ days ago

AHU Technologies logo
AHU TechnologiesWashington, District of Columbia

$50 - $57 / hour

Replies within 24 hours TITLE: Trainer/QA SME Senior LOCATION: Washington, DC/Hybrid MINIMUM EDUCATION: Bachelor’s degree in IT, related field, or equivalent experience. REQUIRED EXPERIENCE: 10 years INTERVIEWS: Webcam Only Job Description: The Senior Software Trainer and Quality Assurance Analyst is a hybrid training/QA role that is uniquely designed to provide schools with expert knowledge and training on the client SIS functions and support the DevOps team in testing. Complete Description: The Senior Software Trainer and Quality Assurance Analyst is a hybrid training/QA role that is uniquely designed to provide schools with expert knowledge and training on the client SIS functions and support the DevOps team in testing and validation new SIS features. The analyst is responsible for providing virtual and in person training and support to schools and central office users. They will provide virtual and in person support and training, in addition to telephone and email support to the end-user community. This role provides resolutions for users, walks the user through a series of steps to determine the cause of a problem, updates systems to reflect users’ requests, and creates training resources to support the ongoing use of the system. The role ensures problem ownership and promotes end-user satisfaction. 1. Create and maintains training resources (manuals, reference guides, webinars, websites) to support ongoing training using a number of mediums: PowerPoint, video, Captivate, Word, SharePoint, etc. 2. Provide virtual and in person training to central office and school-based staff (both at central office and at schools) 3. Interface with other teams on behalf of the training team to improve processes and relationships 4. Serve as the Tier II point of contact for support to resolve SIS user issues 5. Deliver the highest level of customer service to users Log user inquiries in a ticket tracking system. Daily reviews any open issues or requests from end-users and follow-up accordingly. 6. Determine nature of obstacles and best staff to resolve, tracks and Support and carries out the Chancellor’s mission to transform client and close the achievement gap. 7. Perform other related duties as assigned Skills Matrix: · Bachelor’s degree in IT or related field or equivalent experience. Required 5 Years · Excellent customer service, communication, interpersonal skills (both written and verbal). Required 12 Years · Ability to maintain professional communication skills when under pressure and exhibit a high level of patience. Required 12 Years · Must have a wide range of skills and knowledge in computer software and an understanding for network applications. Required 10 Years · Producing training materials using video, Word, PowerPoint, and Camtasia, or Captivate. Required 10 Years · SME in complex enterprise level projects. Required 5 Years · Must have exposure to or experience in the education sector preferred. Required 4 Years · Must have knowledge of Adobe Captivate. Required 4 Years · Help Desk ticket tracking systems (remedy, HEAT, etc.) Required 4 Years · Student Information System - SIS capabilities. Required 4 Years · 5 consecutive years of experience training users in Aspen SIS or other student information systems within or other educational settings. Highly desired 5 Years Flexible work from home options available. Compensation: $50.00 - $57.00 per hour About Us AHU Technologies INC. is an IT consulting and permanent staffing firm that meets and exceeds the evolving IT service needs of leading corporations within the United States. We have been providing IT solutions to customers from different industry sectors, helping them control costs and release internal resources to focus on strategic issues. AHU Technologies INC. was co-founded by visionary young techno-commercial entrepreneurs who remain as our principal consultants. Maintaining working relationships with a cadre of other highly skilled independent consultants, we have a growing number of resources available for development projects. We are currently working on Various projects such as media entertainment, ERP Solutions, data warehousing, Web Applications, Telecommunications and medical to our clients all over the world.

Posted 2 days ago

FleetPride logo
FleetPrideIrving, Texas
FleetPride is the largest after-market distributor of heavy-duty truck and trailer parts in the U.S. with some of the best and brightest people in the business! Partner with the best in the heavy-duty industry and apply today! The QA Lead will be responsible for providing leadership to the Quality Assurance team, including Functional, Integration, E2E, Performance and other areas of testing. This role requires you to have automation experience in either TOSCA or UiPath. This role will be a hands-on role in providing testing for applications like Salesforce, TMS, OMS, etc. Experience in Digital and eCommerce is a good to have for this position. This role will be responsible for leading projects by working with resources (Onshore and Offshore). This position will be a member of the Quality Assurance team and report to the QA Manager. Essential Tasks Prepare all documentation for test strategy, test plans, test estimates, test cases and test scripts. Work with the Onshore and offshore team members to track the work daily. Design, develop, and execute test strategies and plans. Perform the integration and system testing activities. Experience in creating test plans, UAT plans, reviewing test cases/scenarios with other stakeholders. Experience with API testing using Postman or SOAP UI Experience and proficient with basic SQL/database testing Manage working relationship between QA team, Development team, Product team, Business stakeholders. Deliver planning, execution, and reporting for project/program testing activities. Work with extended team to resolve quality issues. Execute application test cases and issue remediation tasks. Assist with application transition to UAT. Provide the required support for UAT testing. Work with the Business analysts and development teams’ group to assist in creating test scenarios, and application verification. Responsibilities Directly work with the team of QA Analysts (Onshore and Offshore) Thorough knowledge of the entire SDLC (Waterfall/Agile), IT systems and processes, testing methodologies and their direct implementation to projects Good Understanding of Retail Supply Chain from eCommerce, OMS (Order management), WMS (Warehouse management), TMS (transportation management) standpoint Thorough knowledge of the test planning and test management domains Experience in analyzing and decomposing requirements and creating testing strategy/plan as well as testing estimates and test plans. Thorough working knowledge of developing, maintaining, and executing test scenarios and test cases. Experience tracking and retesting defects and reporting status to various levels of the project organization. Excellent analytical and problem-solving skills Team player with ability to work in a rapidly changing environment utilizing good time management and prioritization skills, while maintaining high quality and being flexible to customer needs and timelines. Develop appropriate documentation and artifacts throughout the project lifecycle. These may include items like use cases, application diagrams, test plans, test cases, or end user documentation. Participate in assigned aspects of business continuity & the business continuity process plan and testing for application systems. Provide regular status updates and feedback. General Attributes Ability to handle large initiatives/programs and multiple initiatives in parallel. Strong experience in TOSCA, CI/CD and Azure DevOps integration. Detail oriented in test planning and reporting. Ability to lead the UAT testing for multiple projects, provide guidance and follow the appropriate processes. Must be detail oriented, organized, service oriented and responsible. Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things. Considering the relative costs and benefits of potential actions to choose the most appropriate one. Understanding the implication of new information for both current and future problem-solving and decision-making. Able to motivate themselves and a team to work together in the most efficient manner. Able to perform effectively with supervision, either independently or as a team member. Comprehensive knowledge of supported applications. Able to maintain confidentiality of information and systems. Must be available and willing to work on weekends and holidays as we determine are necessary or desirable to meet business needs. Will be required to always carry a cell phone and expected to respond to urgent calls in a timely manner. Excellent interpersonal, written, and oral communication skills required. Strong customer service and presentation skills. Able to execute other duties as assigned. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Reaching above shoulder heights, below the waist or lifting as required to file documents or store materials throughout the workday. Long periods of time spent sitting or standing while working with a computer. Occasional lifting of items up to 50 pounds (files, computer printouts on occasion) The ability to work through stressful situations with either a co-worker or a customer. May require overtime, weekend work and overnight travel. Much of the work shift is spent viewing a computer monitor and using a keyboard while entering problem description details into a case management system. Environmental/Atmospheric Conditions The primary environment is characterized by ambient room temperatures, lighting and traditional office equipment found in a typical office environment. Minimum Qualifications Education Bachelor’s degree in relevant technical field preferred. Professional Experience/Competencies 6+ years of Lead experience related to handling onshore and offshore teams 12+ years of experience in testing applications in the retail environment. 7+ years of strong experience in TOSCA or UiPath automation Relevant experience and demonstrated iSeries (AS400) and eCommerce skills. Good SQL and analysis experience and techniques. Experience with testing tools qTest, HP ALM etc. Experience with Defect tracking tools like Jira or Azure DevOps. Strong skills with the MS Office product suite or comparable applications. FLEETPRIDE is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, or genetic information. FleetPride is the leader in the industry comprised of retail, service, distribution and wholesale divisions. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Posted 4 days ago

Alphia logo
AlphiaPittsburg, California
Job Description: JOB PURPOSE: The Level I QA Technician position is intended to be a “starting” point, from which the technician is expected to advance to capability on both sides of the process before the two year “target .” The Level I Technician should be capable of the required sampling and testing on either the processing or packaging side of the process with some assistance from the other QA technicians or leads . The Level I Technician should have a good working knowledge of Food Safety and Quality policies . DESCRIPTION OF ESSENTIAL DUTIES: Analytical Instruments : Operate the NIR, Aw meter, CompuTrac moisture analyzer, calipers, LECO, laboratory weigh scales, vacuum chamber for seal checks (PC), thermometers and other equipment as added. In-Process Sampling and Testing : Completes all routine tests for either Processing side or Packaging side. Quality Hold Know and be able to place materials and product on Hold in X3 and physical Hold, and complete Log and Hold report. Business Systems : Enter data collected from routine tests into IQS software. Knowledge and proficiency in all Alphia Business Systems as relates to Position. Food Safety and Sanitation : Know and follow basic GMP requirements. Know and monitor HACCP compliance in-Process. Perform verification checks of metal detectors and magnets in area of responsibility as specified in Quality Checkpoints . Assist with product changeover cleaning and sanitation; perform inspections before product startup. Microbial Testing : Pull finished product samples for product release testing. Regulatory Requirements : P ull samples for testing as in product specifications. Communication: Informs operators and shift supervisor of testing results. Communicates Quality concerns and Quality status to the following shift. Responsible for following established procedures to ensure that Alphia produces safe, quality food, meeting all governmental regulations. Other duties as directed or assigned. QUALIFICATION 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). Education level: high school diploma or GED . Willing to work in a team environment and contribute to group goals. Excellent communication skills Ability to receive and provide instructions positively. Basic math skills Ability to multi-task. PHYSICAL DEMANDS: ( The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job . Reasonable accommodation may be made to enable individuals with disabilities to perform the essential function . The phrases “occasionally,” “regularly,” and “frequently” correspond to the following definitions: “occasionally” means up to 25% of working time, “regularly” means between 26 and 75% of working time, and “frequently” means 76% and more of working time.) While performing the duties of this job, the employee is regularly required to talk or hear, walk, and move from place to place . The employee is occasionally required to sit, use foot/feet to operate machine, stoop, kneel, crouch or crawl or reach above shoulders . The employee is frequently required to stand and use hands to finger, handle, or touch . The employee must be able to climb stairs and ladders. The employee must exert 20 to 50 pounds of force occasionally, and / or up to 10 to 25 pounds of force frequently , and / or greater than negligible up to 10 pounds of force constantly . Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. WORK ENVIRONMENT: ( The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job . Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions). The employee may be frequently exposed to allergens and/or airborne particles in the production area . Production employees are exposed to temperatures ranging from 50 to 115 degrees, depending on the season and workstation, and may be working near moving mechanical parts. Occasional exposure to outdoor weather conditions may occur. The noise level in the work environment may be loud while production equipment is running. Personal Protection Equipment (including boots, gloves, safety glasses, and/or face shields) is during various processes in the production area. Ear plugs and bump caps are always in the production area. The above statements reflect the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation. Alphia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Posted 6 days ago

Hewlett Packard Enterprise logo
Hewlett Packard EnterpriseSunnyvale, California

$106,000 - $243,000 / year

QA/Automation EngineerThis role has been designed as ‘Hybrid’ with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work. We help companies connect, protect, analyze, and act on their data and applications wherever they live, from edge to cloud, so they can turn insights into outcomes at the speed required to thrive in today’s complex world. Our culture thrives on finding new and better ways to accelerate what’s next. We know varied backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. If you are looking to stretch and grow your career our culture will embrace you. Open up opportunities with HPE. Job Description: We are looking for a detail-oriented and proactive QA/Automation Engineer to validate and automate testing for Mist Systems’ Network Access Control (NAC) product. You will design and execute both manual and automated test cases, ensure seamless integration with Juniper products and third-party identity services, and help maintain high product quality through robust automation. Key Responsibilities: Design, develop, and execute manual and automated test cases for NAC components (policy enforcement, device onboarding, posture checks, MDM integration, etc.) Collaborate with Product Managers and Developers to create comprehensive test plans Validate integrations with Mist Dashboard, Juniper switches, access points, and external identity services (Azure AD, Okta, RADIUS) Automate end-to-end workflows using Python, REST APIs, and relevant frameworks Simulate network conditions using virtual labs or physical testbeds Maintain CI/CD pipelines for automated test execution Perform regression, performance, scalability, and security testing Analyze logs, debug issues, and document detailed bug reports Support debugging of live production customer issues Required Qualifications: Bachelor's degree in Computer Science or related field, Master's degree preferred 5+ years in QA or Automation engineering (networking or security products preferred) Strong networking fundamentals (TCP/IP, VLANs, DHCP, RADIUS, 802.1X, NAC) Automation experience with REST APIs, Python, and related frameworks Cloud-native platform and microservices testing experience Proficiency with Wireshark, Postman, Jenkins, Docker, and Git Excellent troubleshooting, communication, and documentation skills Preferred Qualifications: Experience with Mist Systems, Juniper, or other NAC solutions (Cisco ISE, Aruba ClearPass, FortiNAC) Knowledge of SAML/OAuth2, Azure AD, Okta, Zero Trust, and endpoint posture checks Familiarity with test management/reporting tools (e.g., TestRail) Additional Skills: Cloud Architectures, Cross Domain Knowledge, Design Thinking, Development Fundamentals, DevOps, Distributed Computing, Microservices Fluency, Full Stack Development, Security-First Mindset, Solutions Design, Testing & Automation, User Experience (UX) What We Can Offer You: Health & Wellbeing We strive to provide our team members and their loved ones with a comprehensive suite of benefits that supports their physical, financial and emotional wellbeing. Personal & Professional Development We also invest in your career because the better you are, the better we all are. We have specific programs catered to helping you reach any career goals you have — whether you want to become a knowledge expert in your field or apply your skills to another division. Unconditional Inclusion We are unconditionally inclusive in the way we work and celebrate individual uniqueness. We know varied backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. Let's Stay Connected: Follow @HPECareers on Instagram to see the latest on people, culture and tech at HPE. #unitedstates#networking Job: Engineering Job Level: TCP_03 States with Pay Range Requirement The expected salary/wage range for a U.S. -based hire filling this position is provided below. Actual offer may vary from this range based upon geographic location, work experience, education/training, and/or skill level. If this is a sales role, then the listed salary range reflects combined base salary and target-level sales compensation pay. If this is a non-sales role, then the listed salary range reflects base salary only. Variable incentives may also be offered. Information about employee benefits offered can be found at https://myhperewards.com/main/new-hire-enrollment.html . USD Annual Salary: $106,000.00 - $243,000.00 HPE is an Equal Employment Opportunity/ Veterans/Disabled/LGBT employer. We do not discriminate on the basis of race, gender, or any other protected category, and all decisions we make are made on the basis of qualifications, merit, and business need. Our goal is to be one global team that is representative of our customers, in an inclusive environment where we can continue to innovate and grow together. Please click here: Equal Employment Opportunity . Hewlett Packard Enterprise is EEO Protected Veteran/ Individual with Disabilities. HPE will comply with all applicable laws related to employer use of arrest and conviction records, including laws requiring employers to consider for employment qualified applicants with criminal histories. No Fees Notice & Recruitment Fraud Disclaimer It has come to HPE’s attention that there has been an increase in recruitment fraud whereby scammer impersonate HPE or HPE-authorized recruiting agencies and offer fake employment opportunities to candidates. These scammers often seek to obtain personal information or money from candidates. Please note that Hewlett Packard Enterprise (HPE), its direct and indirect subsidiaries and affiliated companies, and its authorized recruitment agencies/vendors will never charge any candidate a registration fee, hiring fee, or any other fee in connection with its recruitment and hiring process. The credentials of any hiring agency that claims to be working with HPE for recruitment of talent should be verified by candidates and candidates shall be solely responsible to conduct such verification. Any candidate/individual who relies on the erroneous representations made by fraudulent employment agencies does so at their own risk, and HPE disclaims liability for any damages or claims that may result from any such communication.

Posted 1 day ago

Jbs Usa logo
Jbs UsaMarshalltown, Iowa
Description Position at JBS USA QA Tech – Cold Side Division/Department: Pork Location: Marshalltown Job title: Cold - QA Technician Reports to: QA Supervisor – Shift Supervisor Internal applicants must have less than 3 attendance points in order to apply Nonexempt Hourly Rate: Type of position: Full-time Shift 2 nd Hours: Nonexempt General Description: Inspect designated areas for cleanliness and sanitation to ensure efficient and effective daily operation. Perform regular audits of products to ensure quality and cleanliness. Monitor and record condition of equipment, boxes, facilities, and temperatures of room, product, trailers, sterilizers. Complete necessary paperwork (i.e., sanitation report, etc.). Verify accuracy of scales, equipment, and labels. Observe hourly employees to ensure proper procedures are being followed. Attend meetings as scheduled of called. Perform various other duties as needed or assigned. Required skills: Be able to communicate written and verbally in English Be able to work all 3 shifts as needed Some heavy lifting required Able to work in both hot and cold temperatures Attention to detail a must. Internal Applicants Preferred Education Requirements (if applicable) High school diploma or equivalent Approved by : Marisela Ramirez Title: Employment Manager Posting Date : 12/15/2025 Closing Date: 12/25/2025 Apply online @ jobs.jbss a .com JBS is an Equal Opportunity Employer EOE /DISABILITY/VETS

Posted 1 week ago

Faith Technologies logo
Faith TechnologiesMenasha, Wisconsin
You’ve discovered something special. A company that cares. Cares about leading the way in construction, engineering, manufacturing and renewable energy. Cares about redefining how energy is designed, applied and consumed. Cares about thoughtfully growing to meet market demands. And ─ as “one of the Healthiest 100 Workplaces in America” ─ is focused on the mind/body/soul of team members through our Culture of Care . The QA/QC Field Engineer Intern is a technical assistant to the field, acting as a liaison between the QA/QC Journeyman, Foreman, Superintendents and office. In this role, candidate will support the technical tools (iPads, QA/QC software, BIM360Field, Bluebeam), communicate project specifications needed for and any support details/drawings needed for QA/QC tasks (i.e. details of equipment layout, dimensions, equipment gear windows) needed to keep the field QA/QC resources efficient. The ideal candidate must be proficient in the use of a PC and Microsoft Office Suite, willing and able to learn project checklist and issue management software packages, knowledge of electrical terminology and components is necessary. MINIMUM REQUIREMENTS Education: Enrolled in an accredited institution and actively working toward a Bachelor’s Degree in Engineering, Engineering Technology, or Construction. Travel: Up to 100% Work Schedule: Schedule may vary and can include, but is not limited to: nights, weekends, and holidays. Overtime may be required. Ability to work a flexible schedule is necessary. KEY RESPONSIBILITIES Leads training needs for technology tools, software applications, and SOP’s. Understands relational data sets for equipment and feeders and able to generate reports from such data. Ensures detailed procedures and checklists are in place to document that equipment is installed and energized to the project requirements, applicable standards, as well as customer requirements and specifications. Assembles project information that documents that the installation conforms to project requirements, applicable standards as well as customer requirements. Collects and enters data for KPI reporting and visual reporting. Provide support material and reports to project leads as required. Provide support for commissioning activities. Performs other related duties as required and assigned. The job description and responsibilities described are intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. How Does FTI Give YOU the Chance to Thrive? If you’re energized by new challenges, FTI provides you with many opportunities. Joining FTI opens doors to redefine what’s possible for your future. Once you’re a team member, you’re supported and provided with the knowledge and resources to achieve your career goals with FTI. You’re officially in the driver’s seat of your career, and FTI’s career development and continued education programs give you opportunities to position yourself for success. FTI is a “merit to the core” organization. We recognize and reward top performers, offering competitive, merit-based compensation, career path development and a flexible and robust benefits package. Benefits are the Game-Changer We provide industry-leading benefits as an investment in the lives of team members and their families. You’re invited to review the full list of FTI benefits available to regular/full-time team members. Start here. Grow here. Succeed here. If you’re ready to learn more about your career with FTI, apply today! Faith Technologies, Inc. is an Equal Opportunity Employer – veterans/disabled.

Posted 1 week ago

I logo

Incog Biopharma Services Careers - QA Aseptic Lead/Principal

INCOG BioPharmaFishers, IN

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Job Description

QA Aseptic Principal Job Summary

Join our dynamic Quality Assurance team as a senior technical leader who will shape the future of aseptic manufacturing excellence at INCOG! This is an exceptional opportunity for an experienced QA professional to become the subject matter expert on aseptic processes, contamination control, and regulatory compliance in a fast-growing CDMO environment. You'll work alongside a collaborative team of quality professionals who are passionate about ensuring patient safety while supporting our clients' success in bringing life-saving therapies to market.

As the QA Aseptic Principal, you will serve as the technical authority for all aseptic manufacturing operations, providing critical oversight of media fills, isolator setups, and contamination control strategies. This senior individual contributor role combines hands-on technical expertise with strategic leadership, as you guide training initiatives, represent our systems to regulatory agencies and clients, and ensure our aseptic controls stay ahead of evolving FDA and EMA expectations. You'll have direct impact on product quality and patient safety while helping establish INCOG as the premier CDMO for sterile injectable manufacturing.

Essential Job Functions:

  • Aseptic Process Oversight: Provide quality assurance oversight and approval for all media fills, aseptic setup procedures for isolators, and aseptic process validations to ensure compliance with cGMP requirements; develop and improvesystem reporting document and system improvements to support multi-product, multi-client manufacturing operations
  • Contamination Control Leadership: Develop, implement, and maintain comprehensive contamination control strategies using risk-based methodology across sterile manufacturing operations. Lead multi-functional risk assessment and other technical exercises to assess and improve aseptic conditions and operations.
  • Environmental Monitoring Program Management: Review and approve quarterly environmental monitoring reports, trend analysis, and investigation of excursions to ensure continuous improvement of aseptic conditions
  • Aseptic Intervention Guidance: Serve as the technical authority for evaluating and approving aseptic interventions, including risk assessments, corrective actions, and impact evaluations on product sterility assurance
  • Training and Development: Design and deliver comprehensive training programs for manufacturing floor personnel and QA staff on aseptic technique, contamination control principles, and regulatory requirements; assess on-the-floor trainers' expertise and support the training and assessments of floor operations and operators
  • Subject Matter Expertise: Function as the primary SME on aseptic manufacturing risks, providing technical guidance on complex sterility assurance challenges and emerging regulatory trends
  • Regulatory and Client Interface: Represent INCOG's aseptic systems and controls during FDA, EMA, and client audits, providing technical presentations and responding to regulatory inquiries. Serve as the primary respondent to client and regulatory audits for aseptic topics.
  • Regulatory Compliance Assurance: Ensure all aseptic controls and contamination control measures meet current FDA, EMA, ICH, and other applicable guidance documents and regulations
  • Proactive Regulatory Intelligence: Monitor and analyze FDA and EMA observations, warning letters, and guidance updates to implement preventive measures and maintain competitive regulatory positioning

Special Job Requirements:

  • Bachelor's degree in Microbiology, Biology, Chemistry, Chemical Engineering, or related scientific discipline
  • Minimum 10 years of experience in pharmaceutical manufacturing with at least 8 years focused on aseptic manufacturing and sterile drug product operations
  • Minimum 7 years of Quality Assurance experience with media fills, environmental monitoring programs, and contamination control in a cGMP environment; proven technical leadership through FDA responses and new product introduction
  • Previous experience as a subject matter expert or technical lead in aseptic operations
  • Demonstrated experience with FDA and/or EMA inspections and regulatory interactions
  • Experience with client audits and technical presentations to external stakeholders
  • Demonstrated experience in aseptic operations optimization and improvements, including Annex 1 remediations and ensuring
  • Strong knowledge of USP , FDA Guidance for Industry on Sterile Drug Products, and EU GMP Annex 1
  • Experience with isolator technology, RABS (Restricted Access Barrier Systems), and aseptic fill-finish operations
  • Proven track record in training development and delivery for technical topics
  • Excellent written and verbal communication skills with ability to present to senior management, clients, and regulatory agencies
  • 3-5 years of experience in CDMO or contract manufacturing environment supporting multiple clients and diverse product portfolios

Additional Preferences:

  • Advanced degree (MS/PhD) in relevant scientific discipline
  • Professional certifications such as ASQ CQE, CQA, or equivalent quality certifications

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

By submitting your resume and details, you are declaring that the information is correct and accurate.

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