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Quality Assurance Supervisor – Pharmaceuticals
Lancaster, SC

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Direct Hire

Roles and Responsibilities:

The assistant QA Supervisor is responsible for Supervising those individuals within the QA department that includes but is not limited to the following:

    • QAG and Production process monitoring
    • Assuring that all GMP requirements and regulations are met through compliance to government regulations, industry standards and Company policies
    • Protocol review and approval
    • Reviewing environmental conditions records and responding to excursions
    • Work with Production Supervisors to resolve production problems
    • Document Control
    • Review and approval of SOPs
    • Assuring that all applicable cGMP requirements and regulations are met through compliance to government regulations, industry standards and company policies
    • Batch record documentation review and approval
    • Product/Raw material/Component release (following testing)
  • Working with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Systems activities.
  • Product quality and conformance to government regulations, industry standards, and Company policies.
  • Developing and deploying the Quality systems to ensure products conform to defined requirements.
  • Understanding and deploying processes to assure conformance to government regulations, industry standards and Company policies.
  • Conducting investigations, assessing and closing deviations, determining impact of the issues that could affect product quality, safety and purity.
    • Reviewing customer complaints/AERs to ensure customer satisfaction and potential CAPAs are completed for nonconformance.
    • Reviewing of PMs, Pest Control, Calibration records, etc.
  • Must be able to effectively communicate with other departments and function within a team environment.
  • Must periodically work second and third shift hours in support of personnel on those shifts.
  • Performance of other duties as assigned.

Minimum Requirements: The QA Supervisor must have at least 5-7 years of experience in an FDA regulated manufacturing environment, with 5 years specifically in Quality Assurance or Quality Control. Prior FDA or equivalent inspection experience is highly recommended.

Education and Experience: BS Degree or BA Degree with a Science major or concentration and continuing education credits in the pharmaceutical industry through a reputable professional society. An Associate degree with 10 plus years in pharmaceutical manufacturing experience will be considered.

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