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30 days old

QA Associate II

Kelly Services
Bothell, WA 98021
QA Associate II



Shift: Wed-Sat, 10pm-9am



PURPOSE AND SCOPE OF POSITION:



The Quality Associate II position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant JuMP . 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 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.





**DUTIES AND RESPONSIBILITIES:**



Key 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.





**Education and required Experience:**




+ 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.

+ 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.






**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-11-04 Expires: 2021-01-04

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QA Associate II

Kelly Services
Bothell, WA 98021

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