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