Quality Assurance Role – Astellas Pharma
Astellas is seeking a dedicated Specialist, Quality Assurance for QC to support Quality Control operations within a fast-paced, innovation-driven biotechnology environment. This Quality Assurance role at Astellas Pharma Careers is ideal for professionals passionate about ensuring laboratory compliance, supporting cGMP activities, and contributing to the development of life-changing medicines. Located in Sanford, NC, this position offers the opportunity to work with cross-functional teams while maintaining the highest standards of quality and regulatory compliance. Apply for the Life Science Jobs Now!
Job Details:
- Position: Specialist, Quality Assurance for QC
- Location: Sanford, North Carolina (On-site, cGMP facility)
- Department: Quality Assurance / Quality Control
- Salary Range: $83,300 โ $130,900
- Work Environment: On-site role with occasional travel (0โ5%)
- Shift: May require off-hours coverage and flexibility
About the Company:
Astellas Pharma Inc. is a global pharmaceutical leader operating in more than 70 countries. Committed to turning innovative science into solutions that bring value and hope to patients, Astellas focuses on addressing unmet medical needs through ethical and impactful research, development, and manufacturing. The company is dedicated to improving global health through innovation, integrity, and quality.
Educational Requirements for the QA Role:
Required:
- Bachelorโs degree in a scientific/technical discipline with 3โ5+ years of biotech or pharma experience
OR - Masterโs degree with 1โ3+ years of biotech or pharma experience
Preferred:
- Experience in clinical or commercial manufacturing (Drug Substance/Product)
- Knowledge of method validation and QC processes
- Experience with Laboratory Information Management Systems (LIMS)
Key Responsibilities of the QA Role:
- Oversee QC testing of raw materials, in-process samples, drug substance/product, and environmental monitoring
- Conduct routine walkthroughs to ensure compliance with cGMP standards
- Oversee qualification, validation, and transfer of analytical methods, reagents, and reference standards
- Review protocols, reports, and deviations
- Review and approve laboratory data in LIMS
- Approve CoAs, CoTs, and Product Specification documents
- Lead or support nonconformances, deviations, OOS, and OOT investigations
- Author, review, and approve SOPs, specifications, protocols, CAPAs, and change controls
Skills Required for the QA Role:
- Strong knowledge of QC operations and systems
- Deep understanding of FDA, EMA, ICH, and regulatory guidelines
- Excellent analytical, communication, and problem-solving abilities
- Experience with root cause analysis and CAPA development
- Ability to manage multiple priorities in a fast-paced environment
How to Apply for the Quality Assurance Role?
Candidates interested for the Life Science Jobs can explore career opportunities and apply through the Astellas Pharma career portal. Ensure your resume highlights relevant QC, QA, and regulatory experience.
