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Quality Assurance Auditor

3 months ago

Lancaster, United States Optomi Full time

We are seeking a Quality Assurance Auditor to join our client's team in performing internal and external audits, prioritize audit schedules, and provide corrective actions.


The Quality Assurance Auditor will report directly to the Director of Quality and will also be responsible for developing and maintaining a strong Internal Compliance program.


Roles and Responsibilities:

  • Manage and write reports and audits for approved external suppliers.
  • Conduct audits with a focus on supplier, vendor, and laboratory side experience.
  • Ensure compliance with GMP standards.
  • Conduct quality checks, create findings reports, and develop strategies to enhance stability using standard testing parameters.
  • Recommend opportunities to generate more resources and increase revenues.
  • Support training and readiness for regulatory inspections.
  • Report audit metrics to Quality Assurance and department management.
  • Communicate effectively with all levels of the organization and departments within the organization and function within a team environment.


Minimum Requirements:

  • Must have a minimum of 5+ years of Quality Assurance Auditing experience in a GMP/cGMP environment
  • External vendor/supplier compliance auditing within an FDA regulated industry
  • Direct experience in pharmaceutical, food, or medical device industries
  • Knowledge of Dietary Supplement Regulations
  • ASQ Certified Auditor (CQA) Certification or similar
  • Must be proficient in MS office suite


Education Requirements:

  • B.A. or B.S. in Science or Technical field required