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QA Associate - FDA and Batch Record Exp. Needed

Company: Alpha Consulting
Location: Bothell
Posted on: May 5, 2021

Job Description:

QA ASSOCIATE FDA AND BATCH RECORD EXP. NEEDEDBOTHELL, WA Project Description: The Quality Associate II position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (JuMP).

  • Review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards.
  • This role directly supports JuMP's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at JuMP with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment.
  • The primary focus of the QA Associate II role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations.
  • Assist the QA department in maintaining the Quality focused culture at JuMP by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications.
  • Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
  • Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
  • Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
  • Review deviations, product non-conformities, and GMP investigations to ensure adequate
  • Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
  • Oversee manufacturing operations during patient material receipt and drug product pack out.
  • Support the review and approval of incoming raw materials, routine preventive and calibration of equipment.
  • Revise Standard operating Procedures as needed. Required Skills:
    • Bachelor's degree in relevant science or engineering discipline is preferred.
    • Minimum of Associates degree and/or equivalent combination of education and experience is required.
    • 2-3 years of relevant cGMP experience.
    • Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
    • Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
    • Hands-on experience with batch record review and product disposition is preferred. This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Kristine: ALPHA'S REQUIREMENT #21-01380MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE#ZR#LI-KN1

Keywords: Alpha Consulting, Seattle , QA Associate - FDA and Batch Record Exp. Needed, Other , Bothell, Washington

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