Quality Assurance Specialist for Biologics Manufacturing
1 day ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at AGC Biologics, a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO).
About the RoleThe successful candidate will be responsible for providing technical expertise and project leadership to our Quality organization, ensuring compliance with regulatory requirements and industry standards. You will engage as a product quality expert with cross-functional teams, including Core Teams, Manufacturing, Quality Control, MSAT, Regulatory, and other departments.
Your primary focus will be on providing assessment, guidance, and/or requirements relating to product quality aspects to support the product lifecycle for both internal and external customers. Additionally, you will act as the main point of contact for major and critical investigations, ensuring all reports performed are scientifically sound and well written.
Key Responsibilities- Provide cross-functional quality leadership and support program deliverables for one or more products/molecules and associated ongoing life-cycle management activities.
- Provide quality perspective, expertise, and decisions as Quality representative on product cross-functional teams.
- Demonstrate success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations.
- Act as the Customer point of contact for quality oversight for one or more products at different stages of the product lifecycle.
- Provide guidance and Quality input to GMP decision making for day-to-day operations.
- Recognize key product quality risks and ensure timely escalation of identified risks to the right levels of the organization.
- Lead Quality Core Team meetings, provide metrics, and discuss agenda topics with clients.
- Provide technical expertise and recommendations relating to product quality and influence solutions.
- Review and approve product-related deviations, change controls, CAPA, and product-specific GMP documentation (protocol, report, technical memo).
- Bachelor's degree in Life Sciences or Engineering required. A Master's degree is preferred.
- Minimum 5+ years of experience in the biotechnology or pharma industry with experience in biologics, or 2+ years with a Master's degree.
- Experience with client interfacing is preferred.
- Knowledge of cGMP and US & international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals.
- Must have experience writing, reviewing, approving, and managing GMP documentation and quality system events.
$83,920 - $115,390 per year, depending on qualifications and experience.
About AGC BiologicsAGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.
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