QA Associate - FDA and Batch Record Exp. Needed
Company: Alpha Consulting
Posted on: May 5, 2021
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
- 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
- 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
- Provide Quality support to Manufacturing personnel on the
floor; provide guidance during GMP events and initiation of
- 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
- Bachelor's degree in relevant science or engineering discipline
- 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
Keywords: Alpha Consulting, Seattle , QA Associate - FDA and Batch Record Exp. Needed, Other , Bothell, Washington
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