QA Associate

Bothell, Washington

Exciting Opportunity: Join Our Team as a QA Associate!

Position: QA Associate (Onsite)

Work Schedule: Wednesday – Saturday, 6AM – 4:30PM EST

We are a leading player in the biotech industry, dedicated to excellence in manufacturing quality pharmaceutical products. Our commitment to innovation and compliance with regulatory standards drives our success, and we are seeking a talented QA Associate to join our team.

Job Summary:

  • As a QA Associate, you will play a crucial role in ensuring the quality and compliance of our products. This onsite position involves maintaining shop floor quality presence, performing batch record reviews, inspecting, and releasing intermediates or packaged drug products, drafting specifications and SOPs, and providing essential support during daily walkthroughs of GMP areas.

Key Responsibilities:

  • Maintain quality presence on the shop floor, overseeing materials and finished products.
  • Investigate and resolve GDP errors to ensure product integrity.
  • Perform thorough batch record reviews and approve for product release.
  • Inspect and release intermediates or packaged drug products according to specifications.
  • Monitor processing stages and associated paperwork for compliance with standards.
  • Draft and review specifications and SOPs to maintain regulatory compliance.
  • Provide support and guidance to junior staff members as needed.

Requirements:

  • Bachelor’s degree in Biology, Chemistry, or related field preferred.
  • Minimum 2 years of relevant experience, with a focus on product quality.
  • Knowledge of biotech product manufacturing processes and cGMP regulations.
  • Experience with Oracle, BMRAM, MES, Veeva Infinity is a plus.

If you’re ready to take the next step in your career and contribute to our mission of excellence, we want to hear from you! Apply now to join our team and be part of a company that’s shaping the future of biotech manufacturing.

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. 

 

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