Specialist QA
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Specialist QA
Ref No.: 18-08866
Location: Woburn, Massachusetts
Position Type:Scientific (T)
Start Date / End Date: 07/09/2018 to 07/08/2019
Our client, a leading biopharmaceutical company is looking for a Specialist QA. This is for an initial duration of 12 months and is located in Woburn, MA
 
Top Skill Sets:
Min of 5 years previous experience in the below areas
  1. QA
  2. Investigations
  3. Compliance areas
  4. Training and quality systems
  5. Flexible to work with different quality processes and managing multiple priorities at the same time.
 
Job Details:
  • Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
  • Cross-functional quality responsibilities will include investigation support, review of change controls, NC/CAPA/Change Control management, review of documentation, day-to-day quality support.
 
Responsibilities include:
  • Review and Approval of Investigations, CAPAs, and Change Controls
  • Audit and Inspection Support for quality processes
  • Review and approval of documentation
  • Support generation, review and approval of documentation
  • Metrics reporting
  • Own and drive to closure Investigations, CAPAs, and Change Controls
  • Support training activities
  • Support program alignment and integration into the client Quality Systems
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.