CEL - QA ASSOCIATE
Job Number: 21-07152
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!
- Plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (JuMP). Primary responsibilities include the review of cGMP batch records, product receipt and packaging.
- 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.
- 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.
- 0-2 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
- Hands-on experience with batch record review and product disposition is preferred.
- Strong computer skills with Word and Excel and other electronic manufacturing systems.
- Detail oriented team player with effective planning, organization and execution skills.
- Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
- Good organization and time management skills.
- Ability to work in a high paced team environment.
- Strong written and verbal skills.
- 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.
- 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 release of routine preventive maintenance and calibration of equipment.
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:
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.