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QA Specialist

  • Location: Boston
  • Salary: US$28.00 - US$40.00 per hour per hour
  • Job Type:Contract

Posted 14 days ago

The Operational Area Quality Specialist will provide QA support of analytical laboratory operations. This role will review data clinical and commercial analytical, release and stability data, including deviations, in-process data, and other quality systems documentation as needed in support of product disposition.

Responsibilities include but are not limted to:

  • Performs analytical data review for commercial release and stability and verify documentation and determines acceptability by using standard operating procedures.
  • Perform quality review/ approve of raw data and COAs in support of commercial batch release when needed.
  • Upload the vendor created protocols in QDocs and update all commercial stability-controlled documents in QDoccs including Vendors Stability Protocols, Initiation Forms, and Data Tables. In addition, update JMP files for all commercial products if needed.
  • Provide support to Clinical analytical data review as needed
  • Support the day-to-day management of the analytical data from external CMO - Update trackers in a timely manner upon receipt of data from external vendors and follow up for any major delays or issues.
  • Communicates proactively with internal and external partners and management.
  • Assists department mgmt. with monthly/quarterly Quality System data review metrics and reporting
  • Escalate critical and major finding to Quality management related to GXP Operational areas

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