Quality Assurance Specialist

Location: Summit, New Jersey Salary: 401k, medical, dental
Sector: Pharma et Biotech Type: Prestation de services

Job Title: Quality Assurance Specialist

Location: Summit, NJ

Duration: 6 months

Hours: 40 hours per week

Compensation: TBD


  • 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.

Skills/Knowledge Required:

  • 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.