Trabajo de Sr. Quality Assurance Specialist

EPM Scientific

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responsible for: • Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations. • Support development of commercial and clinical GMP systems • Batch record review • Change requests • Deviation & CAPA review • Lot release • Work directly with CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs to ensure quality oversight of aforementioned operations • Assist with QA decision, direction, and leadership in assigned interdepartmental meetings. • Assist with regulatory inspections. The Quality Assurance Specialist should have the following qualifications: • Bachelor's in life sciences or business required • 2-5 years in life sciences industry related experience • 2+ year of experience with batch record review and lot disposition Benefits: • Healthcare (Medical, Dental, Vision) • Competitive Pay Rate • 12+ month contract w/ extension and conversion possibilities

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