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QC Analyst, Method Validation

Location: Cambridge, Massachusetts Salary: US$30 - US$55 per hour
Sector: Pharma & Biotech, Quality Assurance (QA), Quality Assurance (QA) Type: Contract

QA Specialist III

Duties

  • Your primary focus will be providing support and guidance on routine quality - related issues.
  • Provide Quality Assurance review and disposition of commercial lots of drug substance, product and finished goods.
  • Must start, monitor, as well as complete change controls related to Quality topics
  • Prepare and review applicable sections of regulatory submissions

  • Distribute work to Quality Assurance staff to assure timely review of batch documentation,
  • Lead investigation teams and ensure proper close out and follow - up.
  • Lead off-site visits and teleconferences for discussion and review of supplier performance to established schedules and cGMP compliance.
  • Create and/or review deviations and investigations to assess cGMP compliance of lots.

Requirements

  • 3-5 years of direct GMP experience in Pharma, Biologics or Solid Dosing Capacity.
  • BA/BS (or Masters) in any Life Science discipline preferred, and/or 8+ years experience in GxP Drug Manufacturing industry.
  • Microsoft office skills.
  • Proven project management skills/ multitasking skills in previous roles - planning, projects etc.
  • Will need to both understand and apply good working knowledge of quality and GMP principles
  • Positive work attitude, must support teamwork and continuous improvement.
  • Must have the ability to handle multiple tasks concurrently and in a timely fashion.
  • Wrist and hand motion are required (e.g. writing, typing)

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