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Quality Assurance Manager - Pharmaceuticals
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Job Location: Lancaster, SC
JOB DESCRIPTION

Job #: 29217
Title: Quality Assurance Manager - Pharmaceuticals
Job Location: Lancaster, South Carolina - United States
Employment Type:
Salary: $90,000.00 - $120,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: Negotiable

WHY IS THIS A GREAT OPPORTUNITY?

We are looking for a Quality Assurance Manager to report to the Senior Quality Assurance Manager. This person supervises Document Control, Batch Release, Product Returns, Complaints, and AHPAERs.

JOB DESCRIPTION

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.
QUALIFICATIONS

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.

Education:
University - Bachelor`s Degree/3-4 Year Degree




How to Apply:


 
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