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Quality Assurance Associate- Microbiology Testing
$70,000 - $90,000/Yr
Rk Pharma - Pearl River, NY
posted 2 months ago
Full-time - Mid Level
Pearl River, NY
Chemical Manufacturing
About the position
The Quality Assurance Associate position at RK Pharma Inc. focuses on ensuring compliance with cGMP regulations and quality control standards in the microbiology testing domain. The role involves reviewing documentation, conducting internal audits, and collaborating on quality assurance processes as the company prepares for commercial manufacturing.
Responsibilities
- Review Quality Control documentation to ensure compliance with company procedures and cGMP and 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.
Requirements
- A science degree specifically in Microbiology.
- Experience working in a cGMP regulated environment for at least 3 years or similar educational equivalency.
- Experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology.
- Strong Quality Control background preferred.
Benefits
- 401(k)
- Competitive salary
- Dental insurance
- Health insurance
- Opportunity for advancement
- Paid time off
- Training & development
- Vision insurance
