Quality Assurance Specialist

2 weeks ago


Portsmouth, New Hampshire, United States Lonza Full time
Job Summary

A Principal Operations Specialist I at Lonza provides first-level Quality Assurance support for operational areas involved in GMP-related activities. This role assists GMP associates by reviewing batch records, logbooks, and analytical testing results, as well as coaching and mentoring associates on GMP tasks. The QA Principal Operations Specialist I acts as the eyes and ears of Quality Assurance, ensuring the facility is inspection-ready and GMP operations are in compliance.

Key Responsibilities
  • Perform daily rotations through GMP operational areas for documentation review and observation of GMP work habits.
  • Provide coaching and feedback on GMP and documentation behaviors, working with Manufacturing Management.
  • Offer GMP guidance to Manufacturing for routine and non-routine issues, escalating complex issues to senior staff and Management.
  • Respond to QA Hotline calls in support of GMP operations, making simple GMP decisions independently and seeking guidance from senior staff and Management for complex decisions.
  • Document all items within QAOTF shift notes and provide follow-up for other shifts as needed.
  • Authorize placement and removal of Quality Tag Outs and release equipment from Product Changeover.
  • Represent QA in meetings and on project teams, learning decision-making as a QA representative.
  • Perform other duties as assigned.

Requirements
  • High School Diploma required
  • Bachelor's Degree preferred




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