External Quality Assurance Lead
Há 13 horas
External Quality Assurance Specialist About the Role: The External Quality Assurance (EQA) Specialist will provide oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role is critical in supporting ongoing manufacturing campaigns, batch release, and ensuring timely resolution of quality events. Review and approve deviations, Out-of-Specification (OOS) investigations, CAPAs, and change controls from CDMOs and external testing laboratories. Monitor manufacturing campaigns, production activities, and resolve issues during routine manufacturing. Review and approve QC/analytical results and Certificates of Analysis from CDMOs/external labs. Review and approve production lot records for compliance prior to disposition. Perform GMP reviews of incoming documentation (batch records, test data, release packages). Ensure timely escalation and resolution of manufacturing and quality issues. Collaborate with internal cross-functional teams (QA, QC, Supply Chain, Regulatory, CMC) to ensure readiness for release and regulatory filings. Support audit readiness activities for Regulatory Authority inspections. Requirements: Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline. 3 - 5 years of QA experience in the biopharmaceutical or cell/gene therapy industry. Strong knowledge of cGMP, ICH Q7/Q10, FDA 21 CFR Parts 210/211. Experience with CDMO oversight, lot release, and deviation management. Excellent communication and problem-solving skills. What We Offer: A dynamic and collaborative work environment. Opportunities for professional growth and development. Competitive compensation and benefits package.
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Specialist – External Quality Assurance
Há 2 dias
Brasília, Brasil Nexcella, Inc. Tempo inteiroSpecialist – External Quality Assurance São Paulo, Brazil / Remote Nexcella, Inc. Our 3 Core Values - Intelligence - Integrity - Initiative Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting! What You'll Do: The Specialist, External Quality Assurance...
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Quality Assurance Lead
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Brasília, Brasil Insight Global Tempo inteiroContract - 1 Year + Extensions Remote (EST Hours) Lead Quality Assurance / SDET Job Description A client of Insight Global's is looking for two Lead SDETs to help automate the testing environment further. This person will be responsible for working throughout the organization to implement automated testing and training on processes. Required Skills &...
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Operational Quality Assurance Manager
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Quality Assurance Automation Engineer
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Brasília, DF, Brasil beBeeAutomation Tempo inteiroJob Description We are seeking a skilled Quality Assurance engineer to lead our automation strategy and drive quality observability. You will be responsible for building and maintaining a robust automation framework, integrating it with our CI/CD pipeline, and ensuring seamless execution on every pull request. Required skills include expertise in Next.js,...
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Brasília, DF, Brasil beBeeQuality Tempo inteiroTransform Your Career as a Quality Assurance Specialist Come and be part of a leading IT services company where you can grow your career to new heights. We believe that people make the difference, so we foster a culture of unlimited learning, full of opportunities for growth and mutual development. We are looking for a Quality Assurance Specialist who wants...
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Automation Quality Assurance Specialist
1 semana atrás
Brasília, Brasil beBeeQuality Tempo inteiroAutomation Quality Assurance Specialist We are seeking an experienced automation quality assurance specialist to work remotely with a global leader in technology and engineering services. This is a long-term position in the quick serve restaurants industry. The end client operates within the US Pacific Time Zone. A minimum of 10 years of quality...
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Head of Quality Assurance
3 semanas atrás
Brasília, DF, Brasil beBeeQuality Tempo inteiroWe are seeking a detail-driven professional to take on the role of Head of Quality Assurance. The ideal candidate will be responsible for managing a team of 30+ remote assistants and overseeing quality control of job applications. Key Responsibilities Build a Quality Assurance System: Audit current assistants to ensure they meet our high standards. Evaluate...
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Quality Assurance Engineer
2 semanas atrás
Brasília, Distrito Federal, Brasil Jobluno Tempo inteiro US$41.000 - US$90.000 por anoCompany DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time on-site role for a Quality Assurance Engineer based in the Federal District, Brazil. The Quality Assurance Engineer will be responsible for designing and executing test cases, conducting manual and software testing, ensuring quality assurance processes, and reporting...
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Data Quality Assurance Specialist
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Brasília, Brasil beBeeDataQuality Tempo inteiroData Quality Assurance Specialist Job Description Duties and Responsibilities: We are seeking a highly skilled Data Quality Assurance Specialist to join our team. The ideal candidate will have experience in data quality assurance, testing, and analysis. Key Activities: Design and implement effective quality control processes to ensure high-quality data...
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Senior Quality Assurance Analyst
2 semanas atrás
Brasília, Brasil Laboratorios Biopas Tempo inteiroPosition: Senior Quality Assurance Analyst – Pharmaceutical Industry Location: Vargem Grande Paulista, São Paulo, BrazilWork Model: 100% On-sitePosition DescriptionWe are seeking a Senior Quality Assurance Analyst to work on-site at our facilities, with a primary focus on Validation/Qualification, Quality, and Compliance.The ideal candidate will have...