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Senior Quality Engineering Specialist

Prime Medicine
Location
Cambridge, MA
Posted
12 days ago
Department
Quality
What they actually want (must-haves)
  • Bachelor’s degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience
  • At least four years of experience in a regulated life-sciences environment
  • Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements
  • Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records
  • Experience using a computerized maintenance management, calibration management, or equipment tracking system
  • Strong technical writing, organization, and cross-functional coordination skills
Nice to have
  • Experience in biotechnology, gene therapy, cell therapy, or another regulated life sciences environment
  • Familiarity with equipment lifecycle activities or software assurance/CSV practices
  • Experience supporting supplier qualification, vendor assessments, or laboratory instruments and CMMS records
What the job really is

The Senior Quality Engineering Specialist at Prime Medicine is responsible for providing operational support for GxP software, equipment, and vendor oversight. This role involves executing qualification activities, maintaining compliance records, conducting risk assessments of software and suppliers, and ensuring equipment is properly qualified and maintained. The Specialist collaborates with various departments to resolve documentation gaps and supports regulatory inspections and audits.

Benefits
  • Comprehensive Total Rewards package
  • Robust health, financial, and wellness benefits including medical, dental, vision, life insurance
  • 401(k) match
  • Equity programs
  • Generous paid time off
  • Wellness days
Things to weigh
  • No specific mention of remote work options
  • Role involves significant documentation and compliance responsibilities which may be high-pressure
  • Salary range provided but may vary based on experience and skills
Job score3.6/5
Benefits4/5
Freshness5/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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