Quality Assurance Specialist - Biologics
Job Summary
Supporting sterile biologics manufacturing and testing activities, the full-time Quality Assurance Specialist - Biologics will manage product quality complaints, vendor qualification, and quality systems management, with the flexibility to work remotely or onsite.
Key responsibilities
- Support GMP batch review, product disposition, and release activities in collaboration with internal and external stakeholders
- Oversee quality compliance for outsourced manufacturing and testing of sterile biologic products, ensuring adherence to cGMP regulations
- Maintain Quality Management System (QMS) records and assist with inspection readiness activities and audits
Required qualifications
- Minimum 3 - 5 years of relevant experience in the pharmaceutical industry
- Bachelor's degree in Biology, Pharmaceutical Sciences, or a related field
- Working knowledge of cGMP regulations and quality systems
- Previous audit experience
- Ability to work in a dynamic environment with flexibility
Complete Job Description
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