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
- 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.