Related skills
document control phi qms hipaa capaπ Description
- Assist in creating and revising documents and training plans for multiple teams.
- Manage release/updates to Quality System and product docs; operate EDMS.
- Review/approve documents; participate in Quality System meetings as needed.
- Collect/trend quality metrics; oversee QMS processes (Doc Control, CAPAs, deviations).
- Stay current on FDA/ISO13485/CLIA/CAP guidance.
π― Requirements
- Associate degree or certificate, B.A., B.S., or equivalent.
- 2+ years in Clinical Laboratory or Biotech industry preferred.
- Experience with Quality System, document control, CAPA, or regulatory compliance preferred.
π Benefits
- Medical, dental, vision, life and disability plans.
- Free testing for employees and immediate families; fertility care.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Employee referral program.
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