21h ago

Quality Systems Specialist

Burlington, MA

$100k-$125k / year

full-timesenior Hybridbiotech

πŸ›  Tech Stack

πŸ’Ό About This Role

You'll manage the electronic Quality Management System (ZenQMS) to ensure GxP compliance for a clinical-stage biotech company. Your work will directly support drug discovery for central nervous system disorders. You'll collaborate cross-functionally to maintain controlled documentation and training.

🎯 What You'll Do

  • Manage full lifecycle of controlled documents in ZenQMS
  • Ensure documents comply with regulatory and internal requirements
  • Coordinate workflows with stakeholders for timely alignment
  • Provide day-to-day support on document control and quality processes

πŸ“‹ Requirements

  • Bachelor's degree in a scientific discipline
  • Minimum of 5 years in biotechnology or pharmaceutical industry
  • Understanding of FDA, EMA, and ICH guidelines
  • Familiarity with GCP, GMP, and GLP standards

✨ Nice to Have

  • Experience with electronic quality management systems (eQMS)
  • Knowledge of Microsoft Office Suite

🎁 Benefits & Perks

  • πŸ’° Annual Bonus Opportunity
  • πŸ₯ Medical, Dental, Vision Insurance
  • πŸ“ˆ 401(K) Plan with Match
  • πŸ“… Flexible Non-Accrual PTO
  • πŸ‘Ά Parental Leave

πŸ“¨ Hiring Process

Estimated timeline: 2-4 weeks Β· AI estimate

  1. 1Recruiter Phone ScreenΒ· 30 min
  2. 2Hiring Manager InterviewΒ· 45 min
  3. 3Onsite InterviewΒ· 4 hours
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