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Senior QA Specialist

Location: Summit, New Jersey Salary: US$45 - US$50 per hour + benefits package available
Sector: Pharma & Biotech Type: Contract

Senior QA Specialist

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.

Location: Summit, New Jersey

Duration: 6-month contract

Compensation: $45-50 per hour

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.