Manufacturing Associate II

3 weeks ago


Vacaville, California, United States Polaris Pharmaceuticals Inc. Full time
Manufacturing Associate II Job Summary

The Manufacturing Associate II is a key member of the Polaris Pharmaceuticals Inc. team, responsible for the manufacturing of Polaris' drug substance and/or drug product portfolio. This includes support and collaboration with manufacturing customers and partners, including Quality, MSAT, Facilities, and management, that results in safe, high-quality, and continuously improving production, while maintaining full compliance with cGMP regulations and Polaris' corporate principles, quality policies, and standards.

Responsibilities:

  • Perform daily GMP manufacturing operation activities in the cleanroom and AFS areas.
  • Support and collaborate with the Manufacturing leadership team, MSAT, Quality, and Scheduling to meet short and medium-term objectives.
  • Responsible for escalations as needed.
  • Drive a culture of continuous improvement.
  • Develop area technicians in both expertise and production knowledge.
  • Comply with cGMP and GDP regulations.
  • Order and dispense raw materials.
  • Perform inventory cycle counts and site fit-for-use inspections.
  • Perform revision and creation of SOPs, batch records, or associated protocols under a change control program.
  • Perform deviation initiation, investigation, resolution, and CAPA.
  • Maintain Polaris' right-to-operate: Ensure cGMP production of products in compliance with all applicable Health Authority requirements and Polaris' Quality Management System.
  • Ensure systems and processes are properly maintained to ensure staff's safety, product quality, and continuity of supply.
  • Ensure that staff are appropriately trained and qualified for the activities they perform prior to execution.
  • Ensure on-site presence for their staff and themselves.
  • Work overtime as needed, including outside of normal business hours.

Requirements:

  • Bachelor's degree, preferably in Life Sciences or engineering, with 2-3 years of relevant work experience, or associates degree and 4+ years of relevant work experience, or high school diploma and 5+ years of relevant work experience.
  • Knowledge of large molecule biopharmaceutical manufacturing processes and equipment.
  • Ability to work on-site full-time as required.
  • Ability to lift and carry up to 40 pounds.
  • Work overtime as required, including outside of normal business hours.
  • Ability to stand for a prolonged period operating manufacturing equipment, including in an ISO5 cleanroom.


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