Nutramaxlabs Laboratories
  • Lancaster, SC, USA
  • Full Time

Summary of the Position: The Quality Assurance Manager reports to Senior Quality Assurance Manager.  This person supervises Document Control, Batch Release, Product Returns, Complaints, and AHPAERs.  The Quality Assurance Manager is responsible to support all of the day to day operations, techniques, and activities associated with those departments that are used to fulfill the Quality Assurance requirements of the product and/or service.

Roles and Responsibilities:

  • Managing those individuals within the QA department that includes but is not limited to the following responsibilities:
    • Document Control
    • Product Returns
    • 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
    • Finished Product, Raw material, and Component release.
  • Working with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Systems and documentation activities.
  • Product quality and conformance to government regulations, industry standards, and Company policies.
  • Developing and deploying the Quality systems and documentation 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.
  • Performance of other duties as assigned.

 Minimum Requirements: The Quality Assurance Manager must have at least 7-10 years of experience in an FDA regulated manufacturing environment, with 5 years specifically in Quality Assurance and/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.

 

Supervisory Responsibilities:  Quality Assurance staff

 

 

Nutramaxlabs Laboratories
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