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Quality Specialist - III (Senior)
Ref No.: 18-14200
Location: WEST POINT, Pennsylvania
Position Description : Responsible for ensuring that all Client Therapeutic Protein and Biological products managed by BQOEM are manufactured, packaged, analyzed, released stored and distributed in accordance with Client expectations and all applicable regulatory requirements. Ensures the Quality performance of external parties/partners through direct oversight, support and counselling to the partner’s Quality unit. These activities include involvement in most aspects of external manufacturer operations related to the quality of products produced. The incumbent is responsible for the release of all manufactured products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies. The incumbent exercises a leadership role in monitoring and maintaining Biologics External Manufacturing (BEM) compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements.

Position Qualifications: Education Minimum Requirement: BS degree (or equivalent) (Biology, Microbiology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering, etc.) Required Experience and Skills**: Minimum of 5 years’ experience in the pharmaceutical industry with a thorough knowledge and broad experience of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Communicates easily in English both verbally and in writing. Must have very strong relationship building skills. Preferred Experience and Skills: Experience with biologic and/or vaccine Quality Assurance and Quality Control preferable. Experience with SAP based MRP platform and Trackwise change control and customer complaint applications Preferred some level of contractual and financial awareness.