QA Associate

3 weeks ago

Windsor ON, Canada ANI Pharmaceuticals, Inc. Full time

About Us
Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.
With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.

At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential.

About the Role
This is an opportunity to join the QA team at the East Windsor, NJ facility. The position is Monday through Friday from 7:00 a.m. to 4:00 p.m. for the first shift or 4:00 p.m. to 12:00 a.m. for the second shift. This role will follow and ensure compliance with current GMP requirements and ANI SOPs.

Responsibilities
  • Perform room and equipment clearances following internal procedures after cleaning is performed by production.
  • Perform in-process checks while manufacturing and packaging of intermediate and finished product batches.
  • Collect in-process and finished product samples during manufacturing and packaging as per the batch record and protocol.
  • Review batch records online to ensure batch entries are made correctly.
  • Review materials are weighed correctly before initiation of the manufacturing.
  • Monitor production manufacturing areas for compliance with SOP, cGMP, and safety requirements.
  • Ensure batches are manufactured and packaged as per the batch record instructions.
  • Follow and comply with SOP and batch record requirements.
  • Identify and resolve routine errors during manufacturing and packaging to prevent possible deviations affecting production in real-time.
  • Ensure validation batches are manufactured as per the protocol requirements.
Skills
  • Understand the quality and safety requirements per the FDA regulations and SOPs.
  • Follow all defined SOPs.
  • Communicate work-related issues and details effectively with the supervisor and team members.
Requirements:
  • Hold a degree in science or life sciences.
  • 3-5 years of experience working in the pharmaceutical or related industry.
  • Knowledgeable around all FDA regulations and the ability to adhere to SOPs.
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