21h ago
Quality Systems Specialist
Burlington, MA
$100k-$125k / year
full-timesenior Hybridbiotech
π Tech Stack
πΌ 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.
π― 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
π 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
β¨ Nice to Have
- Experience with electronic quality management systems (eQMS)
- Knowledge of Microsoft Office Suite
π Benefits & Perks
- π° Annual Bonus Opportunity
- π₯ Medical, Dental, Vision Insurance
- π 401(K) Plan with Match
- π Flexible Non-Accrual PTO
- πΆ Parental Leave
π¨ Hiring Process
Estimated timeline: 2-4 weeks Β· AI estimate
- 1Recruiter Phone ScreenΒ· 30 min
- 2Hiring Manager InterviewΒ· 45 min
- 3Onsite InterviewΒ· 4 hours
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