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Amadeus logo
AmadeusTorun, WI
Job Title QA Engineer Amadeus is the leading technology provider to the travel industry and is present in 190+ countries around the world. Our innovative solutions power every part of a traveler's journey, from airlines to search engines, travel agencies to hotels, the world's top travel brands rely on Amadeus to help create exceptional traveler experiences. Istanbul is one of our strategic engineering hub locations, hosting business units from across the Amadeus ecosystem and working with multinational teams from around the world to shape and create the future of travel. Summary of the role: The QA Engineer's role is to validate core Amadeus back-end applications, identifying functional issues early in the development cycle to prevent them from reaching production. The responsibilities include reviewing specifications, designing test cases, and creating manual and automated scripts. Additionally, the role focuses on defining, implementing, and rolling out new quality processes. The tooling environment includes distributed systems. In this role you'll find a chance to: Leverage technical and functional expertise to contribute to testing strategies, ensuring alignment with Amadeus' business and quality standards. Participate in specification and architecture reviews, providing feedback on risks and gaps. Define test strategies, plans, and cases (functional and non-functional), ensuring traceability with requirements. Design and execute test cases, validate features, and provide go/no-go decisions based on exit criteria. Maintain and optimize test cases in regression and CI/CD pipelines, addressing flaky tests and adding/removing cases as needed. Assess and implement test automation, contributing to the improvement of frameworks. Manage defects by reporting, investigating, and verifying fixes, ensuring production quality. Report on testing progress and milestones, ensuring clear communication with stakeholders. About the ideal candidate: Collaborative and proactive with a strong focus on quality. Technical and functional expertise in testing back-end applications. Experience in designing and executing test cases, both manual and automated. Adaptable and eager to contribute to continuous improvement. Committed to maintaining high-quality standards throughout the development process. Brings unique perspectives and values diversity. Dedicated to fostering an inclusive and supportive work environment. What we can offer you A critical mission and purpose- At Amadeus, you'll power the future of travel with a critical mission and extraordinary purpose. A truly global DNA- Everything at Amadeus is global, from our people to our business, which translates into our footprint, processes, and culture. Great opportunities to learn- Learning happens all the time and in many ways at Amadeus, from on-the-job training to formal activities, and daily interactions. A caring environment- Amadeus fosters a caring environment that supports both professional growth and personal well-being. A complete rewards offer- Amadeus provides attractive compensation packages, including salary, bonus, caregiving and health benefits and health benefits. A flexible working model- Embrace our flexible working model, enabling you to excel wherever and however you work best. A diverse, equitable, and inclusive community- We are committed to enabling each employee to reach their full potential by fostering a culture of belonging and fair treatment. A Reliable Company- Trust and reliability are fundamental to shaping our relationships with customers, partners, and employees. Application process: The application process is easy and fast. Create your candidate profile manually or upload your CV/Resumé. Are you the one we're looking for? Apply now! #LI-EMEA Diversity & Inclusion Amadeus aspires to be a leader in Diversity, Equity and Inclusion in the tech industry, enabling every employee to reach their full potential by fostering a culture of belonging and fair treatment, attracting the best talent from all backgrounds, and as a role model for an inclusive employee experience. Amadeus is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to gender, race, ethnicity, sexual orientation, age, beliefs, disability or any other characteristics protected by law.

Posted 3 weeks ago

N logo
Neurocrine Biosciences Inc.San Diego, CA

$145,600 - $199,000 / year

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Responsible for driving and leading Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance ("QA") expertise, leadership and training to ensure adherence with applicable regulatory requirements and company policies/procedures. _ Your Contributions (include, but are not limited to): Primary Function Study Team Support: Serve as the CQA Lead for complex programs, including those requiring unblinded CQA roles Develop risk mitigation plans and strategies Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary Provide guidance on remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance Lead site inspection preparation activities and review inspection findings and responses in conjunction with QA management Provide GCP training as needed, including Investigator Meeting training Quality Systems Work with (may lead) a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training Proactively research, test and implement quality systems, processes and procedures within CQA area Develop and assess GCP metrics, conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting. Proactively identify areas for improvement and collaborate with QA and GCP departments on continuous improvement initiatives QA Department Support Partner with QA management to drive strategies to ensure compliance to regulations, guidelines and company SOPs across the organization, and lead QA initiatives as assigned Support all on-site regulatory inspection activities May work on other projects within QA not related to GCP Secondary Functions Good Clinical Practice ("GCP") Audit Management: Lead, plan, conduct, and oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures Develop and lead the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable. Assist in the audit site selection process for study-specific audit plans. Ensure timely audit conduct, reporting, review, and closeout in accordance with Company SOPs Maintain current and accurate audit records, including CQA audit schedules, files, and audit database/tracker Provide proactive audit status and metrics reports to management Other duties as assigned Requirements: BA/BS in life sciences or related discipline or RN and 8+ years of related industry experience, including 4 years in CQA in drug development environment is preferred. Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines OR Master's degree in life sciences or related discipline and 6+ years of similar experience noted above Expert knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired. Experience with gene therapy clinical trials is preferred Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to auditees as well as the Company's management Ability to identify and escalate problems and follow-through with the corrective actions Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors Anticipates business and industry issues; recommends relevant process improvements Demonstrates broad expertise or unique knowledge Considered an expert within the company and may have external presence in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams Excellent computer skills Excellent communication, problem-solving, analytical thinking skills Sees broader picture and longer-term impact on division/company Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $145,600.00-$199,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Posted 30+ days ago

A logo
American Regent LaboratoriesShirley, NY

$21 - $24 / hour

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

Posted 1 week ago

Bristol Myers Squibb logo
Bristol Myers SquibbDevens, MA

$130,020 - $157,559 / year

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Senior Manager, QA Material Review Board role is responsible for the Material Review Board (MRB) process for non-conforming material at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. They will oversee atypical events to ensure the appropriate management notifications occur per procedure. This individual will coordinate with stakeholders to gather supporting documentation and content for the Material Review Boards to facilitate options for delivering Drug Product to patients. The primary stakeholders for this role are QA Disposition, QA/QC/MST Investigations, Medical, Legal, senior site leadership, and other product level teams. This individual will act as MRB Chair, ensure accurate and timely MRB facilitation and follow up, including material conversion, maintenance and review of SOPs, and acts as primary point of contact for MRB. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens. Shifts Available: M-F, Standard Working Hours Responsibilities: Coordinate and prepare for Material Review Board (MRB) meetings by: Monitoring quality events and impact assessments, supporting the MRB Coordinator as needed, for potentially non conforming lots. Review Pre-MRB Notification sent to Management and MRB Stakeholders, and draft as needed to support the MRB Coordinator. Scheduling MRB meetings and deliverables as needed. Oversee/Review coordination and compilation of Material Review Board (MRB) content for presentation to senior leadership, medical affairs, legal, and other program stakeholders as it relates to potentially non conforming lots during the manufacture or testing of Cell Therapy Drug Products. Coordinating, Co-authoring, and review of Integrated Health Hazard Assessment (IHHA) documents as needed. Chair MRB meetings and determining available treatment options for patients, leveraging cross functional analysis by stakeholders Author as needed, and approve MRB Executive Summary with available treatment options and meeting minutes. Own and manage MRB outputs, action items, and Quality records. Record and manage MRB action items and approve MRB Record actions in electronic system. Own and manage MRB and material conversion business processes at the manufacturing site by assuring local compliance with applicable BMS Policies, Guidelines, and Directives and ensuring consistency with site and global procedures and/or specifications. Provide support, as needed, to the MRB Coordinator in execution of Material Conversion activities. Drive improvement initiatives related to MRB and Material Conversion. Act as subject matter expert and present MRB and Material Conversion program overviews during inspections and audits. Coaching and training new MRB coordinators. Support Disposition organization as needed. Knowledge and Skills: Ability to research, understand, interpret and apply internal policies and regulatory guidelines Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications Advanced ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation. Ability to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principles Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy Ability to work in a fast-paced team environment and lead team and cross-functional stakeholders through changing priorities. Ability to think strategically, meet deadlines and prioritize work. Able to independently work across and influence cross-functional groups and network teams to ensure requirements are met. Ability to motivate and foster a positive team environment Confident in making decisions, able to anticipate Quality issues and proactively solve problems Curious and ability to think critically to create innovative solutions Experience working with protected health information Demonstrated experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. Demonstrated proficiency with electronic system and databases Basic Requirements: Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 8+ years of experience in a regulated industry, preferably with 4+ year of quality system or lot disposition experience. BMSCART #LI-ONSITE GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $130,020 - $157,559 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/ . Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Posted 30+ days ago

Super Micro Computer, Inc. logo
Super Micro Computer, Inc.San Jose, CA

$100,000 - $135,000 / year

Job Req ID: 27816 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing company among the Silicon Valley Top 50 technology firms. Our unprecedented global expansion has provided us with the opportunity to offer a large number of new positions to the technology community. We seek talented, passionate, and committed engineers, technologists, and business leaders to join us. Job Summary: Supermicro is seeking a talented Software QA Engineer with great attention to detail and strong problem-solving ability to join our software team. You will be responsible for examining all aspects of the products/applications, performing tests. If you are a forward-thinking engineer who can bring software quality improvement ideas and new strategies to lead the company forward, we would love to talk to you. Essential Duties and Responsibilities: Execute software automation. Perform IPMI, Redfish, BIOS, and software tools validation. Perform software user interface, functional, and stress testing. Provide feedback to the design team to improve product quality. Utilize analytical skills to validate and verify software/system issues. Create comprehensive test plans, procedures, and evaluation reports. Perform ad-hoc testing on Gold SKU and OEM systems. Participate in issue review sessions with cross-functional teams including PMs, FAEs, service teams, and customers. Ensure continuous testing coverage for top-priority projects through global team collaboration. Enforce software quality control standards. Qualifications: Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Information Systems, or a related field. 5-7+ years of software quality assurance experience is preferred. Familiarity with SQA requirements and methodologies. Ability to adapt quickly and excel in a fast-paced environment. Creative thinker with a strong passion for quality. Experience with shell scripting and Python is a plus. Experience or familiarity with networking, switch validation, or related test environments is a strong plus. Ability to adapt quickly and work effectively in a fast-paced and dynamic environment. Excellent communication, documentation, and collaboration skills. Salary Range $100,000 - $135,000 The salary offered will depend on several factors, including your location, level, education, training, specific skills, years of experience, and comparison to other employees already in this role. In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation, such as participation in bonus and equity award programs. EEO Statement Supermicro is an Equal Opportunity Employer and embraces diversity in our employee population. It is the policy of Supermicro to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status or special disabled veteran, marital status, pregnancy, genetic information, or any other legally protected status. Job Segment: Testing, Cloud, Quality Assurance, Embedded, User Experience, Technology

Posted 30+ days ago

C logo
Cambia HealthPortland, OR

$86,000 - $141,000 / year

MANAGER QA & REPORTING (HEALTHCARE) Hybrid (In office 3 days/week) within Oregon, Washington, Idaho or Utah Build a career with purpose. Join our Cause to create a person-focused and economically sustainable health care system. Who We Are Looking For: Every day, Cambia's Operations and Compliance Team is living our mission to make health care easier and lives better. The Manager of Quality Assurance And Reporting directs, develops and leads the staff accountable for providing Health Plan Operation Quality Assurance Auditing and Reporting. Accountable for the timely and accurate external corporate reporting for the Blue Cross Blue Shield Association (BCBSA) Local Operations Scorecard (LOS) and Licensee Desk Level Audit (LDLA), as well as Performance Guarantee performance measures. Responsible for the interpretation of LOS, LDLA, and PG policies and regulations and for the implementation of the necessary statistically valid audit procedures to assess these performance measures. May also be responsible for internal high dollar prepay, staff performance auditing activities, external audit support, or compliance audits. Responsible for writing audit programs, evaluating audit results, and reporting to internal Senior Management any quality issues and areas where quality improvement is needed. Primary business contacts include BlueCross BlueShield Association, affiliate Plan LOS or LDLA peers, Member and Provider Experience, Claims, Group and Member Administration, DTS, and Provider Services Division management - all in service of making our members' health journeys easier. If you're a motivated and experienced QA & Reporting Leader looking to make a difference in the healthcare industry, apply for this exciting opportunity today! What You Bring to Cambia: Preferred Key Experience: Experience with AI tools and technologies to enhance productivity and decision-making in professional settings highly desired Qualifications and Certifications: Bachelor's degree in Business, Accounting, Health Care, Management or related field Five years of experience in claims, membership, or customer service activities is desired minimum three years experience in a leadership or supervisory position Equivalent combination of education and experience Skills and Attributes (Not limited to): Ability to communicate effectively, verbally and in writing with all levels of Cambia personnel. Ability to lead and participate in a team environment to achieve department goals and objectives consistent with corporate vision and strategies. Ability to interpret regulations and external reporting requirements, plan for and successfully implement changes in LOS, LDLA, performance guarantee, and staff performance audit requirements, including appropriate sampling methodology, audit oversight, and concise and accurate reporting. Knowledge of audit techniques and statistical sampling methods and procedures including sample sizes, variances, confidence levels, random and stratified sampling, and precision levels. Knowledge of generally accepted auditing procedures and practices, obtained through an auditing course or prior work experience. Knowledge of quality tools and quality improvement methodologies. Demonstrated effective and diplomatic interpersonal skills with all levels of staff and management Demonstrated analytical ability in identifying problems, developing solutions and implementing effective courses of action. Ability to think clearly under pressure and project a professional image at all times. Strong proficiency with personal computer applications including Microsoft Excel, Word, and PowerPoint. What You Will Do at Cambia (Not limited to): Responsible for developing and implementing quality audits throughout Health Plan Operations to ensure that quality service levels are met or exceeded. Prepares and maintains reference manuals and audit programs/procedure guidelines for all Quality Assurance audits and reports. Maintains knowledge of the BlueCross and Blue Shield Association LOS Program, LDLA, and Performance Guarantee Audit measures, standards and reporting procedures. Analyze and report audit results using graphs/trending in order to highlight and prioritize quality improvement opportunities. Identify error trends and work with business areas to reduce repeat errors. Lead cross-functional quality improvement initiatives by collaborating with Claims, GMA, and Member and Provider Experience, and other divisions to implement corrective action plans. Contribute to and/or manage Quality Assurance Audit & Reporting corporate initiatives. Prepare requests for new or changes to existing audit sampling methods and procedures. Tests sampling program changes and directs implementation. Assists with the preparation of the annual budget for the department and monitors monthly operating expenses to ensure they are within budget. Facilitate regular quality review meetings with cross-functional teams to discuss findings, share best practices, and coordinate improvement initiatives. Demonstrate analytical ability in identifying problems, developing solutions and implementing an effective course of action. Help drive the resolution and completion of outstanding Corrective Action Forms (CAF) that involve repeat audit findings. Ensure hiring, performance evaluations, training and employee development promotes improved production and efficiency along with employee satisfaction. Give presentations to staff or management of various departments in such a way as to promote understanding and motivation to improve or maintain corporate performance levels. Direct and evaluate the activities of subordinates to assure work is completed in an effective accurate and timely manner. Responsible for hiring, performance evaluations, training and employee development. Optimize audit processes by leveraging technology where possible. Integrate audit findings into the training and documentation programs to drive continuous improvement. The expected target hiring range for the Mgr QA and Reporting is $92k - $124k is depending on skills, experience, education, and training; relevant licensure / certifications; performance history; and work location. The bonus target for this position is 15% . The current full salary range for this position is $86k / $141k. About Cambia Working at Cambia means being part of a purpose-driven, award-winning culture built on trust and innovation anchored in our 100+ year history. Our caring and supportive colleagues are some of the best and brightest in the industry, innovating together toward sustainable, person-focused health care. Whether we're helping members, lending a hand to a colleague or volunteering in our communities, our compassion, empathy and team spirit always shine through. Why Join the Cambia Team? At Cambia, you can: Work alongside diverse teams building cutting-edge solutions to transform health care. Earn a competitive salary and enjoy generous benefits while doing work that changes lives. Grow your career with a company committed to helping you succeed. Give back to your community by participating in Cambia-supported outreach programs. Connect with colleagues who share similar interests and backgrounds through our employee resource groups. We believe a career at Cambia is more than just a paycheck - and your compensation should be too. Our compensation package includes competitive base pay as well as a market-leading 401(k) with a significant company match, bonus opportunities and more. In exchange for helping members live healthy lives, we offer benefits that empower you to do the same. Just a few highlights include: Medical, dental and vision coverage for employees and their eligible family members, including mental health benefits. Annual employer contribution to a health savings account. Generous paid time off varying by role and tenure in addition to 10 company-paid holidays. Market-leading retirement plan including a company match on employee 401(k) contributions, with a potential discretionary contribution based on company performance (no vesting period). Up to 12 weeks of paid parental time off (eligibility requires 12 months of continuous service with Cambia immediately preceding leave). Award-winning wellness programs that reward you for participation. Employee Assistance Fund for those in need. Commute and parking benefits. Learn more about our benefits. We are happy to offer work from home options for most of our roles. To take advantage of this flexible option, we require employees to have a wired internet connection that is not satellite or cellular and internet service with a minimum upload speed of 5Mb and a minimum download speed of 10 Mb. We are an Equal Opportunity employer dedicated to a drug and tobacco-free workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, age, sex, sexual orientation, gender identity, disability, protected veteran status or any other status protected by law. A background check is required. If you need accommodation for any part of the application process because of a medical condition or disability, please email CambiaCareers@cambiahealth.com. Information about how Cambia Health Solutions collects, uses, and discloses information is available in our Privacy Policy.

Posted 2 weeks ago

Nvidia logo
NvidiaSanta Clara, CA

$128,000 - $201,250 / year

We are seeking energetic, hardworking Software Quality Assurance Engineers to join our Customer Support Team and provide world-class support. Strong Windows OS knowledge and in-depth experience with various PC hardware, debugging technologies. Selected person will work closely with our customers, developers, PMs and internal teams on existing and upcoming NVIDIA products, new features, and technologies. What you'll be doing: Work with software developers, program managers, and customers to investigate reported issues, assist in root cause determination, and verify reported defects are fixed. Replicate Customer / End user reported issues. Candidate will be working on the latest NVIDIA products and technologies and provide software technical support to our customers and partners. Focus will be to analyze and reproduce issues reported by OEMs customers and partners. Additional responsibilities include testing NVIDIA products on customer specific platforms to ensure compatibility and provide timely communication to cross-functional groups. You will help triage, isolate, and resolve reported problems. Develop and implement software tools that improves productivity. What we need to see: Bachelor or Masters degree in Computer Science, Electronics, Software Engineering, or equivalent experience. 5+ years' experience with 2+ years customer support or software -hardware testing experience required. Experience troubleshooting and resolving hardware or software issues a must. Deep understanding of the Windows OS. Extensive scripting using Python required. Deep knowledge of PC architecture, supercomputers, and computer clusters. Must have extensive experience building, configuring, and troubleshooting PCs, or laptop systems. Experience with debugging tools, memory dump analysis and remote debug. Strong interest in or knowledge of CUDA, OpenCL, and deep learning AI. The candidate should be willing to work flexible hours. Ways to stand out from the crowd: Strong interest and knowledge of Generative AI and various LLMs. Automation experience using C/C++, Ansible, Java, JavaScript. Familiarity working with NVIDIA GPU hardware a strong plus as well as prior experience in PC Game Testing will be an added advantage. Strong analytical & problem-solving skills, excellent interpersonal skills and should be able to handle multiple projects independently. Your base salary will be determined based on your location, experience, and the pay of employees in similar positions. The base salary range is 128,000 USD - 201,250 USD. You will also be eligible for equity and benefits. Applications for this job will be accepted at least until October 25, 2025. NVIDIA is committed to fostering a diverse work environment and proud to be an equal opportunity employer. As we highly value diversity in our current and future employees, we do not discriminate (including in our hiring and promotion practices) on the basis of race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law.

Posted 3 weeks ago

Applied Research Associates, Inc. logo
Applied Research Associates, Inc.Madison, AL
The Prototyping Manufacturing and Integration Division (PMID) of Applied Research Associates (ARA), Inc (www.ara.com), has an exciting opportunity for a full-time QA Support Specialist working on-site at our Madison, AL facility. The QA Support Specialist provides support and coordination while assisting in the development and implementation of quality standards to ensure that products meet quality specifications, while working to improve processes and workflows to comply with safety regulations. QA Support Specialist will assist in performing inspections, conduct audits, document deviations, and collaborating with cross-functional teams to uphold the highest levels of quality and compliance. Effectively communicates and delivers reports with proactive, team-oriented, or independent problem-solving and critical thinking skills to provide recommendations for improvement. Must Haves as a QA Support Specialist: Requires a completed Bachelor's degree and 0-2 years' of experience "OR" H.S. diploma or equivalent and 6+ years of experience as QA Analyst Familiarity with Quality Management Systems (QMS) Ability to document and analyze quality data effectively Familiar with implementation of and maintaining ISO 9001 systems or AS9100 Standards Ability to track, analyze, and report quality metrics, including inspection results, nonconformance trends, and feedback Experience in developing, updating, and implementing quality control procedures, inspection checklists, and deficiency tracking systems Ability in identifying opportunities for process improvements through analysis of process measurement data Self-starter with demonstrated efficient work methods High analytical and problem-solving skills while handling multiple tasks in a fast-paced environment Ability to develop relationships and work alongside various functional teams and stakeholders Detail oriented with well-developed organizational skills Must be proficient with Microsoft Word, Excel, and Power Point Proven ability to communicate effectively both in writing and verbally with staff at all levels of the organization Work requires sitting, sitting for long periods of time, pushing, pulling, standing, standing for long periods of time, reaching, grasping, bending, climbing, stooping, hold and move items with hand(s), multilimbed coordination, finger dexterity, arm-hand steadiness, vision for close and distance and must be able to lift up to 50lbs individually, 50lbs or more with assistance Be physically capable of wearing all required personal protective equipment to include, but not limited to safety glasses, respirator, safety shoes, hearing protection and hand protection as required Be a U.S. Citizen with ability to obtain and maintain a SECRET clearance from the US Department of Defense Wish List/Preferred: Active / current SECRET Clearance from the US Department of Defense Experience in an ISO9001/AS9100 manufacturing certified environment ASQ certification or equivalent Who is ARA? Learn more about ARA and Our Core Values at WHO WE ARE - ARA ARA offers competitive benefits that address our employees' needs now and in the future. Learn more about each of our benefits at https://www.ara.com/benefits/ #LI-AB1 Please apply at careers.ara.com for the QA Support Specialist position.

Posted 30+ days ago

Synack logo
SynackSan Mateo, CA

$165,000 - $195,000 / year

Synack's Penetration Testing as a Service platform manages customers' attack surfaces by discovering new assets, pentesting for critical vulnerabilities and gaining visibility into the root causes of security risks. We are committed to making the world more secure by harnessing a talented, vetted community of security researchers to deliver continuous penetration testing and vulnerability management, with actionable results. Synack's PTaaS platform has uncovered more than 71,000 exploitable vulnerabilities to date, protecting a growing list of Global 2000 customers and U.S. agencies in a FedRAMP Moderate Authorized environment. For more information, please visit www.synack.com. We are seeking an experienced and highly motivated Manager, QA Engineering to lead our Agile Quality Assurance and Test Automation efforts. In this pivotal role, you will be responsible for building, mentoring, and guiding a team of talented QA engineers, defining and optimizing our QA processes, and selecting and implementing the best-in-class tools. A key focus will be on driving automation to enhance the efficiency, accuracy, and overall quality of our software products. You will play a critical part in ensuring the delivery of robust, high-quality cybersecurity solutions to our customers. Sounds interesting? Keep reading! Here's what you'll do Lead, mentor, and develop a team of QA engineers, fostering a culture of continuous improvement, innovation, and collaboration. Conduct performance reviews, provide regular feedback, and support career growth for team members. Recruit, onboard, and retain top talent to scale the QA team as needed. Foster strong working relationships with development, infrastructure, product management, and other cross-functional teams. Define, implement, and continuously improve QA strategies, methodologies, and best practices across the software development lifecycle. Establish and maintain clear QA metrics and reporting to track progress, identify areas for improvement, and communicate quality status. Champion a "shift-left" approach to quality, integrating testing activities earlier into the development process, where manual testing is an exception Ensuring QA engineers are leading automation efforts, stories have well-conceived acceptance criteria, and developers and QA engineers are collaborating to write test automation to a high standard Ensure the appropriate level of functional, performance, security, and regression testing is applied Ensure adherence to quality standards and regulatory requirements. Evaluate, select, and implement appropriate QA tools and technologies to support testing efforts, including test management systems, automation frameworks, and performance testing tools. Implement and manage CI/CD pipelines for automated testing, ensuring efficient and rapid feedback loops. Learn new technologies as needed to build tools and improve efficiency and productivity Here's what you'll need Bachelor's degree in Computer Science, Engineering, or a related field; Master's degree, or equivalent experience 5+ years of experience in SDET, with at least 2+ years in a leadership or management role. Proven experience in managing and developing QA teams. Strong understanding of software development life cycles (SDLC) and QA methodologies (Agile/Scrum experience highly desirable). Demonstrated expertise in test automation, including experience with various automation frameworks and tools - Playwright preferred, Cypress, Selenium Webdriver, TestCafe. Experience with BDD tools like cucumber with the automation framework Proficiency writing code in at least one of Python, Golang, JavaScript or Typescript Experience with CI/CD tools and practices (e.g., GitHub Actions, GitLab CI, Jenkins). Solid understanding of cybersecurity concepts and experience testing security-related products is a significant advantage. Excellent communication, interpersonal, and problem-solving skills. Ability to work effectively in a fast-paced, dynamic environment. Experience developing internal tools, and GenAI coding tools such as Cursor, Github Pilot to improve developer experience and productivity You have excellent debugging skills in diagnosing issues in a multi-tier web architecture Comfort with writing and reading code, and a basic understanding of data structures Hands on experience with automation framework design and development from scratch when/where/why/how to test (we use git) Understanding of virtualization and containerization technologies Understanding of Cloud technologies, like AWS, GCP, Azure Experience analyzing logs using GCP, Splunk, or ELK Nice to have Experience testing GenAI and Agentic systems Experience with testing cloud based products/applications Knowledge and understanding of different kinds of VPNs Experience with load and performance testing Ready to join us? Synack is committed to embracing diversity. Our people are our strength. Each addition to our team is an opportunity to grow and diversify our ideas, experiences, and viewpoints. Synack strives to be inclusive of all people. As a candidate, Synack cares about your privacy. Please view our candidate privacy policy here. This position has responsibility to ensure Synack's security and privacy posture is maintained. $165,000 - $195,000 Salary is determined by a combination of factors including location, level, relevant experience, and skills. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. The compensation package for this position may also include equity, and benefits. For more details about our benefits, please see here. Then for the Employer code, enter: synack

Posted 30+ days ago

KBI Biopharma logo
KBI BiopharmaDurham, NC
Job Summary: The MQA Manager/Sr. Manager is responsible for supervising the MQA team who supports the Manufacturing Process and Areas as part of a GMP Contract Manufacturing Organization. MQA Manager/Sr. Managers are expected to provide sound guidance to internal MQA team and customers with respect to process, SISPQ of product, and risk. The MQA Manager/Sr. Manager's team shares responsibility for the inspection readiness of the site. MQA Manager/Sr. Manager routinely work on the cleanroom floor directly with the MQA and Manufacturing team to provide real time guidance and support. The Manager/Sr. Manager must adhere to procedures and policies to work on the Manufacturing floor. MQA Manager/Sr. Manager routinely collaborates with Manufacturing and work on team initiatives. The MQA Manager/Sr. Manager is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site. Job Responsibilities: Lead, assess, mentor, and develop departmental associates. Level load work across team to ensure timely review/approval of Quality items in support of manufacturing and batch release timelines. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities. Coach QA Specialists to achieve proficiency for the process execution, reviewing/approving executed process records SOPs, DTRs and Deviations. Manage the process proficiency for the site. Oversee MQA support of Manufacturing. Work directly with functional areas to review and approve process procedures. Report KPI's and collaborate with functional areas to improve the Site Quality Systems and streamline processes. Coordinate client communications for batch record comment resolution. Address client comments with internal SMEs and driving client approvals. Represent Quality in required client meetings, which includes obtaining client metrics and presenting in client meetings. Attend relevant operational meetings in support of Manufacturing Operations and disposition activities. Support Client Audits and Regulatory Inspections as required. Minimum Requirements: Knowledge, Skills, Abilities BS and 10+ years' experience (Manager), MS and 8+ years' experience (Sr Manager) in a QA or cGMP environment in Biopharmaceuticals or equivalent. Experience in providing Quality guidance to manufacturing to include Deviations/CAPAs and Change Controls, with 4+ years of supervisory experience. Demonstrates strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills. Strong understanding of FDA, EU, and ROW cGMP regulations. Experience and knowledge of worldwide regulatory requirements with emphasis on regulatory requirements for biotechnology-derived product. Experience managing data, metrics, and presenting to senior management. Demonstrate strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills. Demonstrated track record in the following key areas: Strong orientation for Quality and Customer Service Demonstrated level of respect for individuals High level of integrity and personal responsibility Record of innovation Strong collaboration and team building skills. Language Ability Ability to read, analyze, and interpret English documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write technical correspondence that is easy to follow and understand. Ability to make effective and persuasive presentations on controversial or complex topics to senior management peer group, employee groups, and customers. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with a variety of abstract and concrete variables in situations where only limited standardization exists. Physical Demands Use of hands and fingers to manipulate office equipment is required. Position may require sitting or standing for long hours of time. Support manufacturing and warehouse operations to include movement, gowning, and/or lifting Computer Skills Proficient in Microsoft Excel, Microsoft Word, Outlook, PowerPoint, and Internet. Ability to use enterprise software, such as Document Management Systems, Learning Management Systems, Asset Management Systems, Electronic Lab Notebooks, Enterprise Resource Planning systems or similar programs. Equipment Use Knowledge of and experience using a Computer, Telephone, Copier, Printer, Scanner KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 1 week ago

S logo
Synechron IncBelgrade, MT
At Synechron, we harness the power of digital transformation to drive business success. As a global consulting firm, we combine creativity with advanced technology to deliver innovative solutions across industries. Recognized with multiple employer awards, we are committed to building talented teams and creating a dynamic work environment. We are hiring an Senior Automation QA Engineer Hybrid working model - Novi Sad or Belgrade Office We are seeking a highly skilled Senior Test Engineer with expertise in both manual testing and test automation to ensure the quality and reliability of our software products. This role involves designing, implementing, and maintaining automated test frameworks while also performing thorough manual testing for complex scenarios. Key Responsibilities: Define and implement test strategies for new and existing features Collaborate with product owners, developers, and QA teams to understand requirements and acceptance criteria Design, develop, and maintain automated test scripts using tools like Selenium, Cypress, Playwright, or similar Integrate automated tests into CI/CD pipelines (e.g., Bamboo, GitHub Actions) Ensure scalability and maintainability of automation frameworks Execute functional, regression, integration, and exploratory tests Identify, document, and track defects using tools like JIRA or similar Validate fixes and perform root cause analysis Conduct performance tests using tools like JMeter Provide detailed test reports and metrics to stakeholders Maintain clear documentation of test cases, scripts, and processes Your Profile: 5+ years of experience in software testing, with at least 3 years in automation Strong knowledge of Java for automation scripting Familiarity with API testing (Postman or similar tools) Experience with CI/CD tools and version control (Git) Ability to design comprehensive test cases and perform exploratory testing Experience with automation tools like Selenium, Cypress, Playwright, JMeter, Postman Strong analytical thinking, problem-solving, and communication skills Plus is if you have: Experience with cloud environments (AWS, Azure) Knowledge of BDD frameworks (Cucumber) Experience with Trading workflows in Fixed income Understanding of fixed income markets and products, especially Loans Experience working with large-scale, low-latency systems in a trading environment What We Offer: Competitive salary based on your experience and skills Flexible hybrid working model supporting work-life balance Access to continuous development through training and certifications Private health insurance plan FitPass membership to support your well-being and mental health support programs Comprehensive Referral Rewards Program Note: Possession of a valid work permit for Serbia is a requirement for this position. We appreciate the interest of all applicants. Please note that only candidates with relevant IT recruitment experience and a strong network will be contacted for the next steps. All applications will be handled confidentially. SYNECHRON'S DIVERSITY & INCLUSION STATEMENT Diversity & Inclusion are fundamental to our culture, and Synechron is proud to be an equal opportunity workplace and is an affirmative action employer. Our Diversity, Equity, and Inclusion (DEI) initiative 'Same Difference' is committed to fostering an inclusive culture - promoting equality, diversity and an environment that is respectful to all. We strongly believe that a diverse workforce helps build stronger, successful businesses as a global company. We encourage applicants from across diverse backgrounds, race, ethnicities, religion, age, marital status, gender, sexual orientations, or disabilities to apply. We empower our global workforce by offering flexible workplace arrangements, mentoring, internal mobility, learning and development programs, and more. All employment decisions at Synechron are based on business needs, job requirements and individual qualifications, without regard to the applicant's gender, gender identity, sexual orientation, race, ethnicity, disabled or veteran status, or any other characteristic protected by law. Candidate Application Notice

Posted 3 weeks ago

N logo
Neurocrine Biosciences Inc.San Diego, CA

$145,600 - $199,000 / year

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Responsible for driving and leading Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance ("QA") expertise, leadership and training to ensure adherence with applicable regulatory requirements and company policies/procedures. _ Your Contributions (include, but are not limited to): Primary Function Good Clinical Practice ("GCP") Audit Management: Lead, plan, conduct, and oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures Develop and lead the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable. Assist in the audit site selection process for study-specific audit plans. Ensure timely audit conduct, reporting, review, and closeout in accordance with Company SOPs Maintain current and accurate audit records, including CQA audit schedules, files, and audit database/tracker Provide proactive audit status and metrics reports to management Quality Systems: Work with (may lead) a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training Proactively research, test and implement quality systems, processes and procedures within CQA area Develop and assess GCP metrics, conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting. Proactively identify areas for improvement and collaborate with QA and GCP departments on continuous improvement initiatives.QA Department Support: Partner with QA management to drive strategies to ensure compliance to regulations, guidelines and company SOPs across the organization, and lead QA initiatives as assigned Support all on-site regulatory inspection activities May work on other projects within QA not related to GCP Secondary Functions Study Team Support: Serve as the CQA Lead for complex programs, including those requiring unblinded CQA roles Develop risk mitigation plans and strategies Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary Provide guidance on remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance Lead site inspection preparation activities and review inspection findings and responses in conjunction with QA management Provide GCP training as needed, including Investigator Meeting training Other duties as assigned Requirements: BA/BS in life sciences or related discipline or RN and 8+ years of related industry experience, including 4 years in CQA in drug development environment is preferred. Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines OR Master's degree in life sciences or related discipline and 6+ years of similar experience noted above Expert knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired Experience with gene therapy clinical trials is preferred Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to auditees as well as the Company's management Ability to identify and escalate problems and follow-through with the corrective actions. Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors Anticipates business and industry issues; recommends relevant process improvements Demonstrates broad expertise or unique knowledge Considered an expert within the company and may have external presence in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams Excellent computer skills Excellent communication, problem-solving, analytical thinking skills Sees broader picture and longer-term impact on division/company Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $145,600.00-$199,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Posted 30+ days ago

C logo
CellPoint Mobile IncIrving, TX
Senior QA Automation Engineer Location: Dallas Join CellPoint Digital: Shape the Future of Payments with Us! At CellPoint Digital, we're revolutionizing the way businesses in the air, travel, and hospitality sectors manage their payments. With our Leading Payment Orchestration Platform, we're turning payments into a strategic advantage, helping clients optimize their payment experience to boost profits, maximize approvals, lower costs and take control of their payment, resulting in more money to the bottom line. We believe payments should be a strategic asset, delivering financial, customer, and operational value. Our vision is to unify the payment ecosystem, opening up a world of opportunities for leading brands in the air, travel, and hospitality industries. We transform the payment supply chain from a cost center into a profit engine, turning every transaction into an opportunity for growth and competitive advantage. At our core, we're innovators and problem-solvers united by five key values: Mission First, Ownership, Trust & Transparency, Drive, and One Team. We're ambitious professionals who embrace accountability and transform payments together. Our diverse community spans the globe, with hubs in Buenos Aires, Bogota, Copenhagen, Dallas, Dubai, London, Mexico, Miami, Pune, Singapore, and Sofia, along with remote team members worldwide. We celebrate the unique perspectives and experiences that make our team extraordinary. Join us as a Senior Quality Assurance Automation Engineer on our mission to turn payments into possibilities! Senior Quality Assurance Automation Engineer We are currently seeking a seasoned QA engineer with years of experience working with complex systems from the perspective of quality assurance to join us. The emphasis in this role is not to drive business features forward, but to ensure that the quality of implementation is high for those features. This role requires close collaboration with both business partners and developers. You will be embedded in the team, and your role will encompass all aspects of quality assurance, from code-level reviews to ensuring business requirements are sound. Primarily, you will work closely with the product owners to ensure acceptance criteria for stories are encoded in Gherkin. You will be working with a modern stack based on Golang, with infrastructure built on Google Cloud Platform. Customers will be served from multiple regions using a global load balancer to ensure high availability, fault tolerance, and low latency. Our development methodology is agile, using Behavior Driven Development. We use techniques from Domain Driven Design to carve out our micro-services. We aim to work towards discrete and frequent releases using feature-branches, feature toggling, and continuous deployment. Common principles such as API First, Top-Down Development, and micro-services are common lingo in our engineering teams. How You Will Make an Impact: Analyze complex business requirements with a QA perspective and provide constructive feedback to ensure testability and clarity. Proactively collaborate with product managers, developers, and other stakeholders to identify requirement gaps and improve quality outcomes early in the SDLC. Perform exploratory testing during planning and early development phases to uncover edge cases and refine acceptance criteria. Author comprehensive test plans and clearly structured test cases using Gherkin syntax to support Behavior Driven Development (BDD). Develop and maintain automated acceptance tests within a modern test automation framework (preferably Playwright). Contribute to building internal QA documentation, including user guides and testing procedures. Investigate and support resolution of production issues by identifying root causes and contributing regression test cases. Partner with developers to identify and define unit and integration test coverage, ensuring robust test pyramids. While the focus is on automation, contribute to manual testing efforts as needed during exploratory or pre-release testing. Skills you will have fine-tuned: Proven experience with Behavior Driven Development (BDD); deep familiarity with Cucumber and Gherkin is essential. Hands-on experience with end-to-end automation frameworks such as Playwright (preferred), Selenium, Cypress, or similar. Proficient in Typescript and comfortable contributing to automated test suites within a modern CI/CD pipeline. Deep understanding of software testing methodologies, test lifecycle management, and SDLC best practices. Experience with distributed systems and the challenges of testing them effectively. Strong debugging, problem-solving, and analytical skills to identify test failures and system defects quickly. Bonus: Familiarity with payment systems, transactional workflows, or payment gateway integration. Excellent written and verbal communication skills for documenting test strategies and collaborating across teams. Comfortable working in a fast-paced, agile environment with multiple priorities and stakeholders. Self-starter with a solution-oriented mindset and a passion for improving software quality. Able to work effectively in a remote-first, globally distributed team environment. What's in it for you: We offer you the opportunity to be an innovator, challenge the status quo, and redefine the payments category Competitive salary in a fast-growing start-up Rewards & Recognition system Opportunity for personal and professional growth in a dynamic industry Work from anywhere in the world; we're a fully distributed company, and we provide the tools, culture, and support to make your work setup work for you Joining a scaling company that is growing and an opportunity to have great impact Occasional travel to Europe (UK, Copenhagen, Bulgaria) What makes CellPoint Digital a leader in the payment landscape isn't just our technology - it's our people and how we work together. We've built a global community where diverse talents and perspectives unite to create innovative solutions. When you join us, you become part of something bigger: a collaborative culture that crosses borders and disciplines, bringing out the best in every team member to deliver breakthrough results for our clients and partners. Together, we are transforming the payments industry - challenging, supporting, and inspiring one another in the process.

Posted 30+ days ago

KBI Biopharma logo
KBI BiopharmaDurham, NC
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: The Quality Systems team is responsible for establishing and continuously improving the Quality Management System (QMS) that supports the site and Global Compliance activities ensuring systems and business processes are robust, effective, and efficient to comply with required regulations, policies, and guidelines governing the manufacture and holding of materials for our company. The Quality Systems departments goal is support of the site teams to achieve a culture of ongoing regulatory readiness and sustained compliance that delivers safe, pure and effect materials to our clinical and commercial clients. The Senior Quality Assurance Specialist- Client Support is a key Individual Contributor and client projects leader on the Quality Systems team, serving as the Quality-to-Quality client liaison. The incumbent collaborates closely with counterparts throughout the Quality team, supporting processes required to ensure compliance with internal quality documents, regulatory requirements, and cGMP for early and late phase clinical and commercial manufacturing. The incumbent will be responsible for providing support for such activities as product release, deviation, complaint and supplier investigation and closure and facilitating associated collaborations. Additionally, the incumbent will support the compilation, analyzing and reporting of associated metrics. The role requires routine interactions with all functions supporting the external network, including interaction with functions across the company's global network. This role is an onsite hybrid role, working a schedule Monday through Friday between the hours of 8:00 am- 5:00 pm. Responsibilities: Serves as QA facilitator for the Quality aspect of client projects: accountable as the Quality lead, actions coordinator and delegate for the site client project team, joint QA and related meetings. Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline. Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues. Escalates issues to leadership as needed. Interfaces with the PMO team to ensure Quality topics are addressed. Supports Batch disposition, fully executing the disposition process as needed. Supports audit / inspection readiness of the site. Participates in regulatory and other quality/compliance report-outs; reviews client audit outcomes to ensure appropriate corrective actions are implemented as assigned. Works with Global Compliance to support Client Audits Supports Deviation Management activities by participating in investigational meetings, activities, writing and approving investigation as needed. Assists with compiling, reviewing/ approving Quality Systems and Compliance documentation and reports. Demonstrates knowledge of Quality Systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles. Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, audit support. Demonstrated ability to keep Project Leads, such as PMs and team members, informed of the status of assigned work. Ability to determine where escalation is necessary. Capability of being flexible as required tasks change and maintain productivity. Requirements: BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 5-7 years of relevant experience as described below. Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations including solid knowledge of global GMP Quality and Regulatory requirements. Minimum of 2 years of previous experience in QA and in a Client-Facing QA or Project Management role Ability to communicate in customer-facing forums to progress issues and obtain positive results. Ability to work professionally with others and facilitate positive interdepartmental interactions with a diverse group of people. Includes ability to navigate conflict to achieve deliverables and drive to targeted outcomes, as well as to resolve differing perspectives with effective negotiation. Listens and is attentive to others' ideas and contributions. Demonstrated ability to be a strong, dependable team-player, yet effective at advancing assignments and projects independently. Voluntarily communicates needs and suggestions clearly and effectively. Demonstrated strong attention to detail and effective investigation, problem solving, and organizational skills. Ability to properly prioritize tasks and manage time effectively. Proactive approach to drive tasks to completion. Excellent written and verbal communication skills. Ability to read, write, and proofread technical documents, investigations, regulatory documents, etc. Ability to compile and analyze data and information from multiple sources Ability to perform basic calculations and data assessment, simple statistics, graphing, plotting data Minimum intermediate proficiency with of Microsoft Office Excel, Word, PowerPoint (Microsoft365). Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS p Ability to sit for extended periods of time. Ability to work on site in a manufacturing environment periodically. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

Smithfield Foods, Inc. logo
Smithfield Foods, Inc.Mason City, IA
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now! THE VALUE YOU'LL BRING: The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section. As part of our Food Safety & Quality Assurance team, you will play an important role in ensuring our products meet the highest standards. You will perform routine sanitation checks, enforce HACCP and USDA regulations, and use your technical expertise to track products from start to finish - identifying issues and driving corrective actions when needed. You will be responsible for monitoring quality in your area, from grading products and documenting results to overseeing sanitation, temperatures, GMPs, and more. Working closely with production teams, you'll help resolve issues, investigate root causes, and improve processes. You'll also support quality programs through training and performance assessment. Your attention to detail ensures our brands - from Smithfield to Nathan's Famous - are delivered safely and with confidence. WHAT YOU'LL DO: The below statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned. Quality Verification: You conduct routine inspections - including process, metal detection, cooking, and chilling - to ensure products meet all quality standards. You identify and act on out-of-spec products, interpret customer specs, and collaborate with teams to correct issues quickly. Quality Improvement: You drive continuous improvement by addressing deficiencies, identifying root causes of failures, and supporting QA programs. This includes training, spec reviews, and collaborating on initiatives to enhance product quality and reduce waste. Food Safety & HACCP Compliance: You help develop and enforce HACCP programs, monitor critical control points, and ensure food safety protocols are followed throughout the production process. Regulatory & Sanitation Oversight: You ensure USDA regulatory requirements are met, assist with food safety documentation updates, and perform pre-op sanitation checks - following up to guarantee proper cleaning and sampling procedures. Communication & Training: You report food safety issues, recommend corrective actions, and support plant training on deficiencies. In the absence of key personnel, you're prepared to step in or delegate responsibilities as needed. WHAT WE'RE SEEKING: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. High school diploma or general education degree (GED), required. For internal candidates with 4+ years of experience with the company, the Company has the discretion to waive educational requirements. Must have the ability to complete required forms in English, which requires the ability to read and write in English. Demonstrates knowledge of quality assurance principles, food science, meat processing, and USDA regulations, ensuring compliance with company and industry standards. Capable of creating, interpreting, and maintaining technical documents, reports, and manuals, with effective written and verbal communication across teams and stakeholders. Experienced in using monitoring equipment, analyzing data, and responding to regulatory or customer inquiries with sound, evidence-based decisions. Proficient in office software and able to interpret and follow instructions in various formats, including written, oral, and visual. OTHER SKILLS THAT MAKE YOU STAND OUT: Associate's degree, preferred Effectively collaborates with others in a fast-paced, dynamic environment while maintaining a respectful, approachable, and team-oriented attitude to foster strong working relationships and a positive workplace culture. PHYSICAL DEMANDS & WORK ENVIRONMENT: The physical demands described here are representative of those an employee should possess to successfully perform the essential functions of this job. The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Office and plant setting. The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals. Noise level in the work environment is usually moderate but can be loud when in the production area. Occasionally lift and/or move up to 50 pounds Specific vision includes close vision, distance vision, and ability to adjust focus. Exposed to temperatures ranging from 30 - 80 degrees, working in warm and cold area simultaneously. Frequently required to stand for prolonged times; walk; use hands to handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. Relocation Package Available No EEO Information Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Posted 1 week ago

I logo
INCOG BioPharmaFishers, IN
Join INCOG Biopharma Services as a Manager of Audits and play a pivotal role in maintaining our reputation as a trusted GMP-certified CDMO. This exciting leadership position offers the opportunity to shape audit strategy, lead regulatory interactions with FDA and EMA, and mentor a dedicated team of audit professionals. You'll be at the forefront of ensuring compliance excellence while working in a collaborative, "All in" culture that values lean thinking and team collaboration. As part of our Quality Systems organization, you'll have direct impact on patient safety and product quality while advancing your career in a growing, innovative company that puts operational excellence at the center of everything we do. This position reports to the Director of Quality Systems and is responsible for leading all audit activities across INCOG's sterile injectable manufacturing operations. The Manager of Audits will oversee internal audit programs, coordinate external regulatory inspections, manage client and supplier audits, and ensure robust audit response and CAPA implementation. This role requires strong leadership skills to manage a small team while maintaining the highest standards of GMP compliance and regulatory readiness in our fast-paced CDMO environment. Essential Job Functions: Lead Comprehensive Audit Program- Manage internal audits, client audits, and regulatory body audits covering all GMP operations, ensuring compliance with FDA, EMA, ICH, and client requirements Lead client audits of INCOG, including coordinating the responses to the client, working with internal teams as well as internal and client QA teams to resolve observations and implement actions and records in response Manage External Regulatory Interactions- Serve as primary point of contact for FDA, EMA, and other health authority inspections, coordinating pre-inspection preparation, leading audit response activities, and managing post-inspection CAPA implementation and regulatory communications Manage internal inspection program, including executing audits, audit reports, and overseeing responses Implement improvements to the system to improve compliance and efficiency of the audit team's operations Direct Team Operations and Development- Manage and mentor 2-3 audit professionals, providing training, performance management, and career development while ensuring adequate resource allocation and team readiness for all audit activities Ensure Documentation and Reporting Excellence- Prepare comprehensive audit reports with risk assessments and corrective action recommendations, maintain GMP-compliant audit documentation, and provide regular management reporting on audit program metrics and compliance status Special Job Requirements: Bachelor's degree in Life Sciences, Engineering, or related field with thorough knowledge of FDA, EMA, ICH regulations and GMP principles for sterile manufacturing operations Minimum 7-10 years pharmaceutical/biotechnology industry experience with focus on quality assurance and auditing, including minimum 3-5 years supervisory or management experience Direct FDA and/or EMA inspection experience and knowledge of international regulatory requirements, computerized systems validation, and data integrity standards Demonstrated experience with regulatory inspections, audit methodologies, risk assessment, CAPA systems, and quality management systems in pharmaceutical manufacturing environment Strong leadership and communication skills with ability to interact professionally with regulatory authorities, clients, and internal stakeholders while managing multiple priorities under pressure Additional Preferences: Advanced degree (MS, PhD) in relevant scientific discipline with professional certifications such as Certified Quality Auditor (CQA) Lean Six Sigma certification or similar process improvement training with experience in validation principles and pharmaceutical manufacturing processes 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

Performance Food Group logo
Performance Food GroupWest Salem, WI
Job Description Works in conjunction with Corporate Quality Assurance on developing and implementing Standard Operating Procedures. Develops product spec sheets, develops customer specific spec sheets, creates and implements finished good quality reviews, and conducts quality checks on incoming raw materials. Review, implement, and train on SOP's, finished good specs, and raw material specs. Coordinate and complete finished good and raw material audits. Serve as recall coordinator and coordinate details of recalls, withdrawals, and holds with Corporate QA and the distribution centers. Participate in quarterly reviews of all in-house ingredients to ensure accurate ingredient and allergen product labeling. Participation in all audits in regard to quality. Performs other related duties as assigned. EEO Statement Performance Food Group and/or its subsidiaries (individually or collectively, the "Company") provides equal employment opportunity (EEO) to all applicants and employees, regardless of race, color, national origin, sex, marital status, pregnancy, sexual orientation, gender identity, religion, age, disability, genetic information, veteran status, and any other characteristic protected by applicable local, state and federal laws and regulations. Please click on the following links to review: (1) our EEO Policy; (2) the "EEO is the Law" poster and supplement; and (3) the Pay Transparency Policy Statement. Required Qualifications Associates/2-year technical 1 - 3 Years Experience working with food safety or implementing food safety programs Proficient with all Microsoft Office Suites Ability to work independently, with minimal supervision, and manage projects with many moving parts Excellent communication skills to effectively communicate with staff and business relations. Highly organized, detail oriented and capable of multi-tasking. Critical thinker who uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Preferred Qualifications Bachelor's Degree Experience working with food safety or implementing food safety programs Proficient with all Microsoft Office Suites Ability to work independently, with minimal supervision, and manage projects with many moving parts Excellent communication skills to effectively communicate with staff and business relations. Highly organized, detail oriented and capable of multi-tasking. Critical thinker who uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Preferred Professional Certification: Must obtain HACCP certification within 90 days of hire.

Posted 1 week ago

C logo
Cencora, Inc.Juncos, PR
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. Responsibilities: Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment. Shift: Administrative Location: Juncos, PR Education: Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience. Preferred Qualifications: Experience with NPI, Change Control, FATs, Validation, and PPQs Skills: Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams. Enhanced skills in leading, influencing and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development. Demonstrate ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills. Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Values/Leadership Practices. This position is for a temporary contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

Posted 2 weeks ago

Broadcom Corporation logo
Broadcom CorporationSan Jose, CA

$101,000 - $162,000 / year

Please Note: If you are a first time user, please create your candidate login account before you apply for a job. (Click Sign In > Create Account) If you already have a Candidate Account, please Sign-In before you apply. Job Description: Seeking a highly focused and motivated test engineer in our software team responsible for comprehensively testing our PCIE switch solution. This role involves holistic validation of PCIe switch functionality, performance, and compliance across various configurations and use cases. The candidate should have an understanding of PCIe protocol- Gen3 & above, a system-level understanding of PCI-E-based designs, and hands-on experience in Python programming. Good understanding of AI/ML clusters, Deep learning models, and GPU Micro benchmarks is a plus. Primary Responsibilities Creation and review of Test scenarios, Test cases, and Test Automation Reviews of design and functional specifications created by the development team to understand product functionality. Execute test activities and work closely with multi-site team of developers and testers Review User Documentation to ensure it clearly documents product functionality Prioritize and manage multiple, parallel tasks, projects & releases Qualifications: Bachelors of Engineering with a minimum of 5 years of hands-on test experience, or Masters of Engineering with a minimum of 3 years of hands-on test experience Requirements: Strong analytical, problem-solving skills & debugging skills. Possess excellent communication skills and need to be a critical thinker and a self-starter. Possess a strong "break feature mentality" Possess a strong engineering mindset to develop thorough test cases Strong PCIE Experience testing with a good understanding of the following areas: PCIe Config Space, Link Training, ACS, Hotplug, Virtualization, P2P, BMC interaction, AER/DPC, Backplanes Experience in utilizing automation scripts in Python - primarily network and system-level programming using Python. Having experience with AMD/NVIDIA GPUs, Communication Collectives- RCCL/NCCL & libraries- RoCM/CUDA is a plus Having experience with NVMe drives and storage tools for stress generation Having experience with pcie test equipment- Protocol/PCIe Analyzers, Protocol Jammers, Load Generators (Medusa tools) Having Networking experience with protocol testing & validations. Experience with L2/L3 protocols especially RoCE( RDMA over Converged Ethernet ) protocol & use cases in AI/ML, HPC cluster is a plus Having Knowledge of deep learning models- NLP, LLMs, Recommendations, Image Classification is a plus Additional Job Description: Compensation and Benefits The annual base salary range for this position is $101,000 - $162,000. This position is also eligible for a discretionary annual bonus in accordance with relevant plan documents, and equity in accordance with equity plan documents and equity award agreements. Broadcom offers a competitive and comprehensive benefits package: Medical, dental and vision plans, 401(K) participation including company matching, Employee Stock Purchase Program (ESPP), Employee Assistance Program (EAP), company paid holidays, paid sick leave and vacation time. The company follows all applicable laws for Paid Family Leave and other leaves of absence. Broadcom is proud to be an equal opportunity employer. We will consider qualified applicants without regard to race, color, creed, religion, sex, sexual orientation, national origin, citizenship, disability status, medical condition, pregnancy, protected veteran status or any other characteristic protected by federal, state, or local law. We will also consider qualified applicants with arrest and conviction records consistent with local law. If you are located outside USA, please be sure to fill out a home address as this will be used for future correspondence.

Posted 1 week ago

Lonza, Inc. logo
Lonza, Inc.Portsmouth, NH
Today, Lonza is a global leader in life sciences operating across five continents. While we work to deliver new therapies, we also support our employees in building rewarding careers. Join us and help shape the future of life sciences. The actual location of this job is on site in Portsmouth, NH. As a QA Specialist III - Raw Materials Compliance, you will provide operational support and ensure compliance throughout the raw material lifecycle, including receipt, storage, handling, testing, dispensing, and disposition. You will also support final product storage and shipping logistics. This role serves as a Subject Matter Expert (SME) for cGMP documentation review and approval, working independently and guiding team members to resolve complex issues. You will collaborate with Supply Chain, Quality Control, and Manufacturing to maintain quality standards and deliver superior customer service. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental, and vision insurance. Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits . What you will do: Perform SAP transactions and other quality functions to support raw material lifecycle. Provide on-the-floor support for raw material requests and guide team members. Review material documents for disposition to ensure timely release independently. Review and approve SOPs, work instructions, and validation documents in DMS. Review and approve records in QMS (e.g., investigations, change controls, CAPAs). Collaborate with Supply Chain, Quality Control, and Manufacturing for raw material support. Lead meetings, participate in projects, and drive process improvements. What we are looking for: Bachelor's degree in science required; equivalent experience considered. 3-7 years of experience in Quality Assurance and GMP environments. Strong knowledge of GMP regulations and raw material compliance. Familiarity with SAP, TrackWise, and Microsoft Office Suite preferred. Excellent communication skills and ability to manage priorities independently. Attention to detail and ability to work collaboratively and lead initiatives. Business-fluent English required. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Posted 4 days ago

Amadeus logo

QA Engineer

AmadeusTorun, WI

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Job Description

Job Title

QA Engineer

Amadeus is the leading technology provider to the travel industry and is present in 190+ countries around the world. Our innovative solutions power every part of a traveler's journey, from airlines to search engines, travel agencies to hotels, the world's top travel brands rely on Amadeus to help create exceptional traveler experiences.

Istanbul is one of our strategic engineering hub locations, hosting business units from across the Amadeus ecosystem and working with multinational teams from around the world to shape and create the future of travel.

Summary of the role:

The QA Engineer's role is to validate core Amadeus back-end applications, identifying functional issues early in the development cycle to prevent them from reaching production.

The responsibilities include reviewing specifications, designing test cases, and creating manual and automated scripts. Additionally, the role focuses on defining, implementing, and rolling out new quality processes.

The tooling environment includes distributed systems.

In this role you'll find a chance to:

  • Leverage technical and functional expertise to contribute to testing strategies, ensuring alignment with Amadeus' business and quality standards.

  • Participate in specification and architecture reviews, providing feedback on risks and gaps.

  • Define test strategies, plans, and cases (functional and non-functional), ensuring traceability with requirements.

  • Design and execute test cases, validate features, and provide go/no-go decisions based on exit criteria.

  • Maintain and optimize test cases in regression and CI/CD pipelines, addressing flaky tests and adding/removing cases as needed.

  • Assess and implement test automation, contributing to the improvement of frameworks.

  • Manage defects by reporting, investigating, and verifying fixes, ensuring production quality.

  • Report on testing progress and milestones, ensuring clear communication with stakeholders.

About the ideal candidate:

  • Collaborative and proactive with a strong focus on quality.

  • Technical and functional expertise in testing back-end applications.

  • Experience in designing and executing test cases, both manual and automated.

  • Adaptable and eager to contribute to continuous improvement.

  • Committed to maintaining high-quality standards throughout the development process.

  • Brings unique perspectives and values diversity.

  • Dedicated to fostering an inclusive and supportive work environment.

What we can offer you

A critical mission and purpose- At Amadeus, you'll power the future of travel with a critical mission and extraordinary purpose.

A truly global DNA- Everything at Amadeus is global, from our people to our business, which translates into our footprint, processes, and culture.

Great opportunities to learn- Learning happens all the time and in many ways at Amadeus, from on-the-job training to formal activities, and daily interactions.

A caring environment- Amadeus fosters a caring environment that supports both professional growth and personal well-being.

A complete rewards offer- Amadeus provides attractive compensation packages, including salary, bonus, caregiving and health benefits and health benefits.

A flexible working model- Embrace our flexible working model, enabling you to excel wherever and however you work best.

A diverse, equitable, and inclusive community- We are committed to enabling each employee to reach their full potential by fostering a culture of belonging and fair treatment.

A Reliable Company- Trust and reliability are fundamental to shaping our relationships with customers, partners, and employees.

Application process:

The application process is easy and fast. Create your candidate profile manually or upload your CV/Resumé.

Are you the one we're looking for? Apply now!

#LI-EMEA

Diversity & Inclusion

Amadeus aspires to be a leader in Diversity, Equity and Inclusion in the tech industry, enabling every employee to reach their full potential by fostering a culture of belonging and fair treatment, attracting the best talent from all backgrounds, and as a role model for an inclusive employee experience.

Amadeus is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to gender, race, ethnicity, sexual orientation, age, beliefs, disability or any other characteristics protected by law.

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Submit 10x as many applications with less effort than one manual application.

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