JVT Advisors

Stability Coordinator

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Location: Bedford, Massachusetts 01730
Employment Type: Contract

Job Description

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.

 

Responsibilities:

  • 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

Requirements:

  • 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.
  • Proficient knowledge in current regulations and guidance documents including cGMP, ICH, FDA, and EMA requirements.
  • BS in Chemistry or other Physical Science preferred

Christian Griffith

Recruiter

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