Quality Assurance Manager
2 days ago
We are seeking a highly skilled Quality Assurance Manager - Supplier Quality to join our team at AmplifyBio. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our suppliers and raw materials.
Key Responsibilities- Develop and implement procedures for supplier qualification, raw material management, and audit programs.
- Maintain accurate records of supplier certifications, licenses, and statements.
- Conduct regular audits of suppliers and internal QMS to ensure compliance with GMP regulations.
- Collaborate with QA Operations team to investigate product quality complaints and quality events.
- Develop and report key performance indicators (KPIs) for supplier quality management and audit programs.
- Bachelor's degree in a relevant scientific discipline (e.g., bioinformatics, biology, biochemistry, chemistry).
- Minimum 6 years of experience in Quality within a GxP biotechnology or pharmaceutical environment.
- Documented experience with Supplier Quality Management and Internal/External Auditing.
- Ability to apply GMP regulations and guidelines related to supplier management.
- Strong interpersonal skills and ability to work in a team environment.
AmplifyBio is a leading contract research organization providing comprehensive services for discovery stage R&D work, preclinical CRO, and manufacturing services for cell, gene, and mRNA-based therapeutics. We are committed to growing and empowering an inclusive community within our company and industry.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender, sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.
Why Join Us- Competitive compensation package.
- Flexible PTO policy.
- Generous paid parental leave.
- Wellness and self-care programs.
- 401(k) match.
- Tuition reimbursement.
- EAP/work-life support system.
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