Stability CoordinatorApply Now
Location: Bedford, Massachusetts 01730
Employment Type: Contract
Contract Length: 6 months
Job Summary: Responsible for maintaining the overall stability program. Responsible for controlling sample receipt, testing, and release process, according to written procedures under cGMP conditions.
- Manages stability samples including receipt, storage and distribution to required departments
- Monitors stability windows and ensures schedule covers stability testing
- Ensures stability testing is completed within the established stability windows and as scheduled
- Ensures timely write-up and reviews of stability testing assays including populating the stability folders
- Coordinates and facilitates monthly stability meetings
- Creates and maintains stability program Key Performance Indicators (KPIs)
- Communicates effectively inter departmentally to aid with lab functions
- Works independently under general supervision and direction
- Works in compliance with CGMP’s
- Requires lab administrative experience and understanding of theories and practices in Medical Device/Drug Product Stability
- High School Diploma/GED and 5 years’ experience in Life Sciences industry
- Experience with data trending and statistical programs (JMP, MiniTab, Excel, etc) preferred.
- BS in Chemistry or other Physical Science preferred
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