GMP QA Specialist
Newton , MA
• Review and evaluate Batch Production Records for API, Drug Product, Packaging and Labeling to ensure all approved procedures were followed and all specifications were met, proper version control and document integrity.
• Prepare dispositions for clinical and commercial products.
• Partner with QC to review protocols and reports associated with stability, method validation and method transfer, as needed.
• Review label proofs and packaging customer requests for clinical trials in domestic and international markets.
• Participate in maintaining effective relationships with vendors.
• Initiate internal deviations, change controls, CAPAs, complaints and participate in review/resolution of CMO non-conformances.
• Write and review SOPs and work instructions, as required.
• Participate and contribute to meetings held by the Quality organization and represent Quality at cross-functional meetings, as required.
• Ensure quality expectations are being met in the areas of Good Manufacturing, Good Distribution Practice and Good Documentation Practice.
• Support the Quality Management Review, and Annual Product Quality Review, as needed.
• B.S. in Life Sciences or related science degree (Chemistry, Biology, Biochemistry, etc.) required.
• 3-5 years QA experience working with, or for, a pharmaceutical contract manufacturer.
• Experience with batch record review, deviations, root cause analysis, CAPAs, Change Control.
• Experience with data review for accuracy, completeness and compliance.
• Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations
• Experience with method and process validation protocol/report requirements preferred.
• Experience with small molecules and oral dosage forms desirable.
• Knowledgeable of FDA cGMP regulations, EU and ICH Guidance, as well as other industry guidance and regulations.