Manufacturing QA Floor Support

Devens, Massachusetts
Industry: Biotech / Pharma
Job Number: JN -062021-65895

Job Description:

  • Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required.
  • Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations.
  • Assure the quality of manufactured products complies with all applicable regulations and guidelines.


Prerequisites:

  • 6-10+ years relevant exp, 2-4 years on product quality
  • Ability to demonstrate quality mindset with good collaborative skills, preferably through biologics experience (cell culture and protein purification experience). Examples are key here
  • Independent decision-making with an ability to understand when to make a decision vs when to escalate. Examples are key here
  • Batch record review and importance of quality review

Additional

  • 6 month intervals, planned for 12+ month contract
  • Days/wk: ~3.5 (alternating 3 and 4 day weeks)
  • Built in 8 hours overtime every 2 weeks, which I like to think of as a job perk
  • Schedule (rotates like this every 2 weeks (assuming B shift) and it does work every other weekend.



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