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10 days old

QA Associate II / Bothell, WA

Kelly Services
Bothell, WA 98021
**QA Associate II / Bothell, WA**



Kelly Services is currently seeking a QA Associate II for one of our top clients in Bothell, WA.



As a QA Associate II placed with Kelly Services you will be responsible for supporting the cGMP quality operations for the Bothell Manufacturing Plant.



Duration: 6 mon



Pay: $25/hr - $34/hr depending on experience



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 by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications. This role directly supports the Release for infusion (RFI) 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.



**PRIMARY RESPONSIBILITIES INCLUDE:**




1. Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.

2. Provides Quality Assurance floor support of manufacturing operations in controlled cleanroom environments.

3. Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.

4. May review and release consumable and raw materials per specifications.



**REQUIREMENTS:**




+ B.S., in Chemistry, Chemical Engineering, Biochemistry or related science disciplines, or its equivalent is preferred.

+ Minimum of Associates degree and/or equivalent combination of education and experience is required.

+ 1-3 years of relevant experience in a regulated environment with at least 1 year focused on product quality.

+ Hands-on experience with batch record review and product disposition is preferred

+ Knowledge of biotech bulk and finished product manufacturing, analytical testing is preferred.

+ Knowledge of US and EU cGMP regulations and guidance.

+ Knowledge of ERP, LIMS, Syncade are a plus



Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email stalvnl@kellyservices.com for questions about the position but please apply online to be considered for the position.





Why Kelly?




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*





Apply Today!





*Available for purchase and administered by a designated third-party vendor




**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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2021-01-08 Expires: 2021-02-08

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QA Associate II / Bothell, WA

Kelly Services
Bothell, WA 98021

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