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Quality Assurance Specialist
Ref No.: 18-04394
Location: New Brunswick, New Jersey
Position Type:Contract
Start Date / End Date: 10/24/2018 to 04/23/2019
TSR is a relationship-based, customer-focused staffing company. For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Industry: Pharmaceutical

One of our most prestigious clients is looking for a Quality Assurance Specialist. This is a long term opportunity located in the New Brunswick NJ area.

Skills required:
  • Support clinical packaging operations area and responsible for quality release of Finished IMP's
  • Provide quality and compliance oversight to clinical packaging operations ensuring compliance with company directives and governmental regulations
  • Perform all product release activities, which include, but are not limited to, review of batch records, and other associated GMP documentation
  • Ensure that disposition decisions (release or reject) are entered into the inventory management system
  • Review clinical label proofs for approval, and clinical label documents for release
  • Review and approval of all documents related to the Quality System such as investigations into quality incidents & manufacturing deviations, corrective and preventative actions, procedural documents, to ensure conformance to cGMP and global regulatory requirements
  • Support the site compliance function during regulatory agency and third party inspections
  • Provide guidance on quality issues to the Packaging group
  • Escalate immediately to the supervisor, any issues impacting product quality
  • Knowledge of science generally attained in chemistry, pharmacy, biology or a related pharmaceutical science
  • Experience in pharmaceutical quality and/or operations at a site level, including 2-4 years experience in a regulated function
  • Experience within a QA/QC environment is an asset
  • Experience with clinical packaging is an asset
  • In-depth knowledge of cGMP regulations