Summary

The Quality Assurance Specialist is responsible for disposition of the API and API intermediates, including the review of completed batch production and laboratory control records of critical process steps before disposition and ensuring that deviations are investigated and resolved.

Responsibilities

• Act as a lead investigator
• Review production batch records
• Perform quality and compliance related activities as assigned
• Track and trend data for annual product review, water trend reports, and metrics
• Author and/or coordinate the completion of assigned reports
• Provide final review and approval of CAPA, laboratory investigations, and GMP procedures, protocols, forms and instructions; ensuring compliance to cGMPs, regulatory filings, and Pfizer policies/procedures
• Perform or assist with audits and participate in inspection readiness plans and activities
• Administer the docume...