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Illinois Employer

Director of Quality Assurance

Illinois Employer, Decatur, Illinois, United States, 62523


Illinois Employer - Director of Quality Assurance

Location: Decatur, IllinoisApply NowThis job was posted by

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Job Posting .Position Overview:Director of Quality Assurance needed with a Master's degree or Foreign Equivalent in Pharmaceutical Operations & Management, Pharmaceutical Management, Pharmaceutical Science, or Regulatory Affairs, and three (3) months of experience as Director of Quality Assurance or Sr. Validation Engineer performing the following job duties:Oversee the Quality Assurance (QA) department operations by setting clear responsibilities and objectives.Host inspections by customers and regulatory bodies and address any regulatory non-compliance issues.Ensure thorough review and approval of media fills, risk assessments, equipment qualification, validation, calibration, batch records, digitization of processes, and procedural guidelines to maintain adherence to regulatory standards.Oversee the review of completed batch records, strategically plan and execute internal and supplier audits to uphold quality standards.Manage the review and approval process for Quality Management System (QMS) documentation, including change control, Corrective and Preventive Actions (CAPA), deviations, and investigations into out-of-specification results.Participate in the recruitment and evaluation of Quality Assurance personnel, contributing to the development of a competent QA team.Collaborate with interdisciplinary teams to ensure the seamless introduction of new products, focusing particularly on validation, sterility assurance, manufacturing process controls, and quality requirements.Benefits:

Health Insurance & PTO.Mail Resumes to:Rising Pharma Holdings Inc.2 Tower Center Blvd., Suite #1401,East Brunswick, NJ 08816Job Location:1222 West Grand Avenue, Decatur, IL 62526

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