iLocatum

Lancaster, SC

Quality Assurance Supervisor – Pharmaceuticals

Job Description: Pharmaceuticals Quality Control Supervisor

The role of the Pharmaceuticals Quality Control Supervisor is to oversee and manage the Quality Assurance (QA) department. Responsibilities include, but are not limited to, the following:

    • Monitoring QAG and Production process
    • Ensuring compliance with government regulations, industry standards, and company policies
    • Reviewing and approving protocols
    • Reviewing environmental conditions records and addressing any deviations
    • Collaborating with Production Supervisors to address production issues
    • Maintaining document control
    • Reviewing and approving Standard Operating Procedures (SOPs)
    • Ensuring compliance with cGMP requirements and regulations
    • Reviewing and approving batch record documentation
    • Releasing products/raw materials/components after testing
  • Working closely with Production, Regulatory Affairs, Marketing, New Product Development, and other relevant departments to stay updated on Quality Systems activities.
  • Ensuring product quality and adherence to government regulations, industry standards, and company policies.
  • Developing and implementing Quality systems to ensure products meet defined requirements.
  • Implementing processes to ensure compliance with government regulations, industry standards, and company policies.
  • Conducting investigations, addressing deviations, and assessing the impact on product quality, safety, and purity.
    • Reviewing customer complaints and Adverse Event Reports (AERs) to ensure customer satisfaction and addressing any nonconformance issues through Corrective and Preventive Actions (CAPAs).
    • Reviewing Preventive Maintenance (PM) records, Pest Control records, Calibration records, etc.
  • Effective communication and collaboration with other departments within a team environment.
  • Occasional work on second and third shift hours to support personnel on those shifts.
  • Performing additional assigned duties as required.

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

Education and Experience: The ideal candidate should hold a Bachelor's degree or higher in a Science-related major or concentration and have completed continuing education courses in the pharmaceutical industry through a reputable professional society. An Associate degree combined with over 10 years of experience in pharmaceutical manufacturing will also be considered.

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