QA Manager - 6 Month Contract

Location: New Jersey Salary: US$50 - US$60 per annum + competitive
Sector: Pharma & Biotech, Medical Devices, Quality Assurance (QA), Quality Assurance (QA) Type: Contract

I am partnering with a clinical stage Biotech based in northern New Jersey who are developing innovative combination products to secure a Quality Assurance Manager on a 6 month contract with a permanent position available upon a successful consultancy period.

Reporting directly to the Senior Quality & Regulatory Director, you will be responsible for the improvement and maintenance of the Quality System, supplier management and both internal & external auditing.

Key Responsibilities:

  • Internal and External audits and will be the appointed senior internal audit Lead and involved in external audits for assigned processes
  • CAPA and Complaints - Facilitate administrative filing and follow up required to initiate, evaluate, and investigate complaint files for closure including any reportability and corrective actions required
  • Supplier Management including driving Supplier CAPAs, non-conformance approvals and review and deviations
  • Maintenance of documentation including Quality procedures, forms and all other Quality Records (including technical file, Device Master Records and Device History Records)
  • Management of eQMS and documentation control, filing and retention
  • Batch Records Review
  • Qualifications and Training - Maintains training documentation and qualifications for employees and contract workers by administration of training
  • Supporting Regulatory Affairs and Pharmacovigilance on required projects

Experience Required:

  • Proven Quality Management System auditing experience in the Medical Device industry (ideally a certified auditor)
  • Combination product experience in a Quality Assurance capacity (preferred)
  • Ability to work autonomously
  • Willing to travel up to 10%

If the above is in line with you experience and interest, apply now!

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