Quality Control Analyst
Company: LanceSoft, Inc.
Posted on: June 25, 2022
Title: Quality Control Analyst IIILocation: Norton, MADuration:
06+ Months (Possible Extension) Job Description:Duties:The Analyst
III, Quality Control will help in the implementation of laboratory
equipment and enterprise/local software systems at Company's GMP
laboratories in Norton, MA supporting drug substance manufacturing.
This position will be heavily focused on Laboratory Equipment
Qualification, Implementation of a LabWare LIMS system, and
validation of QC computerized systems. Demonstrated technical
writing and validation knowledge is required.
- Execute qualification activities, including analytical
equipment qualification per USP . Experience and demonstrated
knowledge of analytical systems and software to support lab system
- 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
- Ensure adherence with applicable SOPs, compendia, and in
accordance with company and regulatory agency policies and
- 4 - 6 years of experience in a GMP laboratory or software
- Experience with QC analytical instrumentation and software
systems (UPLC / UPLC-MS, Karl Fischer, FTIR, TOC, spectroscopy,
- 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
- B.S. in applicable science field
Keywords: LanceSoft, Inc., Brockton , Quality Control Analyst, Professions , Norton, Massachusetts
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