Quality Control Analyst III

Company: WHITRIDGE ASSOCIATES INC
Location: Cambridge
Posted on: May 13, 2022

Job Description:

• Minimum of 4 years of experience in a GMP laboratory or software validation setting
• Experience with QC analytical instrumentation and software systems (UPLC / UPLC-MS, Karl Fischer, FTIR, TOC, spectroscopy, etc.)
• Knowledge of analytical equipment qualification per USP , and software validation in compliance with 21 CFR Part 11 and EU Annex 11 are desired
• Experience with LabWare LIMS and design/implementation is ideal
• Demonstrated technical writing and validation knowledge is required The person who secures this role will:
  • Implement laboratory equipment and enterprise/local software systems
  • Experience and demonstrated knowledge of analytical systems and software to support lab system implementation
  • Contribute to LabWare LIMS system implementation through performance of master data build, validation execution, and setup for QC within established project timelines
  • Validate QC computerized software systems associated with laboratory instrumentation in accordance with 21 CFR Part 11 and EU Annex 11
  • Collaborate with IT Validation group to ensure all deliverables are met and comply with company procedure
  • Author technical documentation (e.g., SOPs, protocols, test scripts, reports, etc.) with guidance commensurate with experience
  • Ensure adherence with applicable SOPs, compendia, and in accordance with company and regulatory agency policies and procedures

Keywords: WHITRIDGE ASSOCIATES INC, Cambridge , Quality Control Analyst III, Professions , Cambridge, Massachusetts