Job Title: Quality Assurance Specialist
Location: Summit, NJ
Duration: 6 months
Hours: 40 hours per week
- Conducts QA review and approvals of facility, utility, lab instruments, manufacturing equipment commissioning and IOP/Q protocols, executed protocols, summary reports, SOPs, and batch records for completeness and accuracy according to cGMP.
- Author QA operational SOPs.
- Completes and provides data for Continuous Quality Improvement for all records reviewed per SOP.
- Provides input/suggestions for revising standard operating procedures during annual review and process changes.
- Reports non-conformances and/or quality related issues when observed.
- Looking for QA Specialist with utility, facility, lab instrument, manufacturing equipment commissioning, IOP/Q experience to review and approve protocols, executed data packs and summary reports.
- Prior qualification and validation experience are preferred.
- Will consider candidates with operational and/or QA experience in analytical lab instruments, manufacturing of drug substance, drug product or biologics.
- Basic scientific understanding.
- Able to exercise judgement within defined procedures.
- Basic knowledge and ability in using Microsoft Office Package.
Sthree US is acting as an Employment Business in relation to this vacancy.