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QC Analyst, Method Validation

Location: Cambridge, Massachusetts Salary: US$33 - US$55 per hour
Sector: Engineering & Validation, Quality Assurance (QA) Type: Contract

QA Specialist III Cambridge

This company is looking for a qualified candidate with 5-6 years of direct GMP experience in Pharma, Biologics or solid dosing capacity. Must have a demonstrated project management/multitasking skills in past roles. You will provide QA review and disposition of commercial lots of drug product, drug substance and finished goods. Initiate, monitor and complete change controls related to Quality topics. The position is focused primarily on giving both guidance and support on routine quality-related issues. You will distribute work to QA staff to assure timely review of batch documentation, as well as generate and/or review deviations and investigations to assess cGMP compliance. You will both prepare and review the applicable sections of both regulatory submissions, as well as the Annual Product Reviews. You will also be required to serve as a QA representative to cross functional project teams such as tech transfer, process validation, as well as process improvements.

Requirements:

  • BA/BS (or masters) in a Life Science discipline is preferred, and/or 8+ years experience in GxP Drug Manufacturing industry.
  • Must have the ability to juggle multiple tasks jointly as well as in a timely fashion.
  • Must be able to work in a team environment, and have great communication skills.
  • Needs to have a proficient background in all Microsoft Office applications, as well as a positive work attitude.
  • Needs to both understand and apply good working knowledge of quality and GMP principles.
  • Must be willing to travel for meetings or client sites.
  • Approximately 10% travel.

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