Quality Assurance Associate Microbiology Testing

1 week ago


Pearl River, New York, United States RK Pharma Inc. Full time
About RK Pharma Inc.

RK Pharma Inc. is a US-based company with subsidiaries in India, dedicated to developing, manufacturing, and selling high-quality and affordable generic pharmaceutical products worldwide.

Job Summary

We are seeking a Quality Assurance Associate to join our team as we scale towards commercial manufacturing. The successful candidate will be responsible for reviewing documentation, ensuring cGMP compliance, and collaborating with the Quality Assurance Manager.

Key Responsibilities
  • Review Quality Control documentation to ensure compliance with company procedures and cGMP.
  • Support the issuance of CoAs and stability studies.
  • Revise quality and compliance standard operating procedures as required.
  • Review Quality Control method validation and method transfer protocols/reports.
  • Assist with Internal Audits.
  • Collaborate in management of deviations/CAPAs/change controls.
  • Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance.
  • Assist in the preparation and review of the Annual Product Review.
Requirements
  • A science degree specifically in Microbiology.
  • At least 3 years of experience in a CGMP regulated environment or similar educational equivalency.
  • Experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology.
  • Strong Quality Control background preferred.
What We Offer
  • Competitive salary.
  • 401(k) plan.
  • Dental insurance.
  • Health insurance.
  • Opportunity for advancement.
  • Paid time off.
  • Training & development.
  • Vision insurance.


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