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Quality Manager

St. Louis $80,000 - $105,000 p/h Permanent

Job Summary:

  • This position helps to manage the QA systems in a regulated biopharmaceutical environment with regards to U.S FDA cGMP and international regulations
  • This person assists in all activities to verify that appropriate, current procedures are followed, and keeps the leadership team fully informed, through verbal and written reports on the status of QA projects
  • This person also manages documents, deviations, Out-of-Specification results, change control requests, customer complaints, customer and internal audits, regulatory authorities’ inspections, training of personnel and certifications for the facility
  • This person organizes and promotes company-wide quality improvement efforts as well as being responsible for administering the Corrective/Preventive Action program
  • Assures compliance with the company's Quality Assurance systems
  • Maintains files on current suppliers, training programs, and the audit/inspection results
  • Reviews and approves manufacturing and packaging batch records, as well as analytical results associated with commercial products as needed
  • Represents the company during internal and external audits, and regulatory authorities’ inspections
  • Manage organizational documentation through the document life cycle
  • Maintain organizational documents and the document management system
  • Identify and investigate the need for documents of various types
  • Ensure that organizational documents go through a documented and approved review-and-approval process before being stored
  • Ensure that internal controls are in place and are functional
  • Ensure security, accessibility, and proper distribution of organizational documents
  • Help develop and enforce documentation design, review, and storage guidelines

Requirements:

  • Bachelor of Science degree in Chemistry/Biology or a related discipline
  • 6+ years of QA experience in a pharmaceutical manufacturing environment
  • 2+ years of leadership experience
  • Strong compliance knowledge of GMP Quality Systems, policies, and regulations
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