Our client, a pharmaceutical company, has an immediate need for a Quality Control Analyst.
- Execute qualification activities, including analytical equipment qualification per USP <1058>.
- 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 procedures.
- 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.
- Minimum of 2–4 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.).
- Experience and demonstrated knowledge of analytical systems and software to support lab system implementation.
- Knowledge of analytical equipment qualification per USP <1058>, and software validation in compliance with 21 CFR Part 11 and EU Annex 11 are desired.
- Experience with LabWare LIMS and design/implementation is desired.