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Job #02865

About our client Our client is a global, publicly traded pharmaceutical company with over 100,000 employees. They are at the forefront in the development and commercialization of therapeutics in multiple indications, and are well known for high quality standards and commitment to innovation. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Supplier Quality Engineer Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in developing, reviewing and improving pharmaceutical contract manufacturer's quality plans and manufacturing processes related to company products 2) Ensure that the contract pharmaceutical facility's quality systems are established and maintained in compliance with applicable local ordinances, state statutes and federal regulations (FDAs 21, CFR 210 and 2) 3) Review batch history records and associated documentation for releasing finished product(s) 4) Ensure that necessary documentation for releasing product is completed prior to release 5) Conduct periodic and special surveys 6) Ensure quality specifications for incoming raw materials, in-process components and finished products are established 7) Direct sampling inspection and testing to determine conformance to standards 8) Ensure that quality specifications are met prior to release for raw materials, in-process components and finished products 9) Review new documents and make changes to existing documents to ensure enhanced quality and productivity while maintaining compliance with FMCNA corporate and FDA requirements 10) Ensure proper maintenance of device master records and device history records Requirements 1) Bachelor's degree in a scientific or Engineering discipline (Chemistry, Microbiology or Biology preferred) 2) Minimum 5 years of experience in quality systems 3) Minimum 2 years of experience in pharmaceutical manufacturing with GMP (for any drug, but not medical devices) 4) Professional quality discipline certifications (CQE, CQA, CQM or RAB) preferred 5) Knowledge of FDA pharmaceutical regulatory requirements and standard QA practices for manufacturing operations (ISO 9001)