Quality Assurance Associate- Microbiology Testing

Description:

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 in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up 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.

Requirements:

If this sounds interesting to you, it’s probably because up to this point you have:

• A science degree, specifically in Microbiology.
• Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency.
• Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology.
• Thrived in an environment where growth and change are rapid.
• Strong Quality Control background preferred.

The main responsibilities for this position are:

• 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.

If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation.

We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.