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Compliance Specialist / Quality Assurance Engineer

Rensselaer, NY

Order: 1216434


Principal Service Solutions is seeking two Compliance Specialist / Quality Assurance Engineer Consultants

Must have a strong QA, Mfg., or Production background in Biopharma; preferably parenteral filling operation. The ideal candidate will have experience with core areas of focus CC, CAPAs Deviations; however, they should also have some level of Auditing and risk management experience to support Auditing activities and CAPA Management. Experience in working with CMOs/ External Mfg is also a plus.

Responsibilities for which the Consultants will be expected to perform.

Drug Product Manufacturing Compliance Specialist

·         Lead and prioritize operations and practices for Deviation investigations, CAPAs, and Change Controls.

·         Conduct investigations to identify actionable root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools.

·         Support audits of new and existing DP Manufacturing partners. Collaborate with Quality Assurance and DP Manufacturing Teams to effectively address observations and drive CAPAs to completion.

·         Responsible for generating and tracking performance metrics.

·         Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement.

·         Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.

·         Maintain required training status on Regeneron specific work instructions and SOP’s.

·         Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance relating to drug product CMOs.


Education and Experience:

  • Minimum of BS/BA in scientific discipline with 5+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).

This is a long term – minimum of 1 year, most likely longer as long as resources wants to stay

Travelers are fine - $5100 per month travel allowance