Job Description

QA Associate
Job Number: 21-05907
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate for our client in Bothell, WA.
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Plays a key role in supporting the cGMP quality operations for the client’s Plant.
  • Primary Responsibilities include the 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 release for infusion timeline from the date of manufacture and will support all activities for routine clinical and commercial product release 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 client by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications.
 
Responsibilities:
  • 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.
 
Qualifications:
  • 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.

Experience:
  • 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.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
 

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 

Application Instructions

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