Manufacturing Specialist, Drug Product Manufacturing in Cambridge, MA at Integrated Resources, Inc

Date Posted: 7/5/2020

Job Snapshot

Job Description

About the role:
  • Responsible for ensuring all raw data and associated documentation generated from contract GMP manufacturing has been collected and verified, according to SOPs and following good documentation practices
  • Partner with Manufacturing representatives and work to resolve any identified issues
  • Maintain product specific databases and provide updates as required to support routine trending activities and continued process verification
About you:
  • A minimum of two (2) years' experience in the preparation and review of batch records or data verification in a GMP environment
  • Familiarity with compliance and regulatory structures including cGMP, FDA and ICH guidelines
  • Motivation to work both independently and collaboratively in a team-based environment
  • Superb attention to detail
  • Prior experience in LIMS or other associated commercial data capture systems
  • Prior experience with quality control, document control and quality systems