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DUTIES AND RESPONSIBILITIES:
Provide Quality Assurance oversight of the commercial manufacturing of final drug product.
Identify and assess quality risk in activities and processes according to regulatory guidelines and Standard Operating Procedures.
Proficient in Quality Systems particularly associated with Operations, Product Disposition, Change Control and Deviations/CAPA.
Work with the Manufacturing department as a production area Quality Assurance representative.
Coordinate and facilitate Quality Assurance related production and production related activities.
Ensure timely issuance of production records, procedures and labels.
Perform on the floor batch record review.
Ensure timely assessment and closure of Deviations/CAPA and Change Controls requests.
Communicate lot disposition pending issues to Management.
Ensure that products are manufactured in compliance with regulatory and GMP guidelines.
Manage and perform area Person in the Plant activities.
Review and approve Manufacturing and Validation documents.
Review and approve Manufacturing Production Records.
Compile and verify all batch related documents into a Final Product lot disposition package.
Review and disposition disposable raw materials and components for GMP use.
Gather metric information for use in continuous improvement of areas of responsibility.
Provide services for Batch Record review and Product Disposition
Packout/shipping support
Deviation review/approval
Related activities associated with manufacturing support in preparation for the upcoming FDA and EMA Inspections, and commercial production
Provide services for Facilities/Utilities and Incoming support
Work Order review/approval, Deviation review/approval, Disposition of raw materials
REQUIREMENTS:
Required: Minimum of 5-8 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. Working knowledge of quality systems and regulatory requirements.
Education: Bachelor