Pharmaceutical Quality Assurance Specialist

3 weeks ago


New City, New York, United States RK Pharma Inc. Full time

RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing. As a mid-stage start-up focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide, we are looking for sharp, driven individuals to help us grow our team.

This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. The ideal candidate should have experience working in a CGMP regulated environment for at least 3 years or similar educational equivalency. Additionally, expertise in wet chemistry, HPLC, GC, spectroscopy, or microbiology is required.

We estimate that this role can be filled by an individual earning between $80,000 and $110,000 per annum, depending on experience and qualifications. If you thrive in an environment where growth and change are rapid, have a strong Quality Control background, and want to collaborate in management of deviations/CAPAs/change controls, then this may be the perfect opportunity for you.

  • Review Quality Control documentation to ensure compliance with company procedures and cGMP.
  • Support 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.


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