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Sr. Quality Assurance Specialist- NJ

  • Contract
  • Up to US$50 per hour + medical/dental/vision
  • Summit, New Jersey
  • Pharma & Biotech

Title: Senior QA Specialist

Location: Summit, New Jersey

Duration: 6-month contract to start, renewable based on performance

A global biopharmaceutical corporation located in Northern Central New Jersey is looking for Senior QA Specialist with utility, facility, lab instrument, manufacturing equipment commissioning, IOP/Q experience to review and approve protocols, executed data packs and summary reports.

The Senior QA Specialist will be responsible for:

1) Author QA operational SOPs.

2) Provides input/suggestions for revising standard operating procedures during annual review and process changes.

3) Reports non-conformances and/or quality related issues when observed.

4) Reviews and approvals of facility, utility, lab instruments, manufacturing equipment commissioning and IOP/Q protocols, executed protocols, protocol deviations, summary reports, SOPs, and batch records for completeness and accuracy according to cGMP.

5) Provides assistance to other QA staff members as needed.

Requirements:

  • Education: Minimum of a Bachelor's degree or similar work experience.
  • Prior qualification and validation experience is required.
  • Will consider strong candidate with operational experience in manufacturing of drug substance, drug product or biologics or QA/QC experience in analytical lab instruments.
  • Must have basic math skills.
  • Must be able to work independently as well as contribute in a team environment.
  • Basic knowledge and ability is using Microsoft Office Suite.

Sthree US is acting as an Employment Business in relation to this vacancy.