Great opportunity to get your foot in the door with one of the top Biotech companies in the Bedford, MA area!
Description:
- Perform batch record review
- Run deviations and investigations
- Manage the CAPA and Change Control programs
- Perform QA review of new and revised procedures, technical protocols, validations and reports
- Perform internal and external audits as assigned including internal Quarterly Walkthroughs
- Provide document control support.
- Issue and reconcile batch records
Preferred Skills:
Quality assurance, batch record review, deviations, capas, change control, audit, iso 13485, root cause analysis, SAP, FDA 21 CFR
Additional Skills & Qualifications:
- BS in the life sciences
- 5+ years industry experience in QA
- Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices.
Experience Level:
Expert Level
Job Type: Full-time
Pay: $60,000.00 - $85,000.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Work Location: In person