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
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