JT030 - MCS MANUFACTURING ASSOCIATE

Quality Consulting GroupThousand Oaks, CA
2dOnsite

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Requirements

  • Bachelor’s degree or associate degree in related area
  • 4 years of Manufacturing experience
  • Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
  • Prior manufacturing experience, basic AI knowledge, MS O365 knowledge
  • Knowledge of Single-use-Systems
  • CFR and Regulatory knowledge
  • Ability to interpret and apply GMP knowledge
  • Basic troubleshooting skills on production equipment
  • Experience with Delta V
  • Experience with lab equipment/testing

Responsibilities

  • Perform auxiliary tasks as needed (Batch Record Review, Closing Deviations, Document Revisions, Protein Concentration Testing).
  • Prepare buffers and media per Manufacturing Procedures (MPs) and SOPs
  • Follow GMP documentation (SOPs, MPs) with strict adherence to safety and compliance
  • Perform and monitor critical processes, including basic troubleshooting
  • Conduct in‑process sampling and operate analytical equipment
  • Execute washroom activities, including cleaning small and large-scale production equipment
  • Maintain an organized and clean workspace
  • Work in a clean‑room environment while wearing steel‑toe shoes, full gowning, hairnet, and gloves
  • Assist in reviewing documentation such as equipment logs and batch records
  • Identify, recommend, and implement improvements related to routine functions
  • Perform operations in the Manufacturing area, specifically for Purification processes.
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