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Quality Specialist - I (Assistant)
Ref No.: 18-13898
Location: West Point, Pennsylvania
Position Description (Please refrain from using any Client specific acronyms – all should be defined at least once) Supports the External Site Quality Leads and Product Quality Managers who have direct oversight of the release of all manufactured products for which the Biologics Quality Operations External Manufacturing (BQOEM) group has oversight. The incumbent is responsible for GMP document management and the generation of reports to support team compliance and GMP release decisions in conformance to all applicable regulatory requirements and Company policies. / Primary Activities Receives guidance on policy issues as well as general and specific direction with regard to operations from the BQOEM Associate Director or BQOEM Director. Key Responsibilities Include: • Performs & oversees document management & administrative filing across stakeholder areas to ensure compliance. • Must be flexible and collaborative to support departmental needs as requested. • Runs queries from SAP and TrackWise to support compliance monitoring and GMP activities • Assures compliance with established policies/procedures of MMD and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign. • Operates in a safe and efficient manner and in compliance with the MMD QO Safety and Health Policy.

Quals--
Position Qualifications: (please provide below) Education Minimum Requirement: BS degree (or equivalent) (Biology, Microbiology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering, etc.) Required Experience and Skills**: Minimum of 2 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. Experience with MIDAS and document management Strong collaboration, organizational and project management skills Communicates easily in English both verbally and in writing. Preferred Experience and Skills: Experience running report queries from SAP and TrackWise system platforms