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1+ months

Quality Associate

Kelly Services
Bothell, WA 98021
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Quality Associate** at a prestigious Fortune 500 company working in **Bothell, WA.**


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title: Quality Associate**


**Pay: $34.96 per hour**


**Roles and Responsibilities** :

The Quality Associate II position plays a key role in supporting the cGMP quality operations. 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 (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.

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.


Bachelors 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.


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 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.


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-30 Expires: 2021-07-01

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Quality Associate

Kelly Services
Bothell, WA 98021

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