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Quality Associate -cGMP Life Science at YOH Services LLC

Posted in Other 30+ days ago.

Location: Bothell, Washington





Job Description:

QA Associateneeded for acontract opportunityfor Yoh Scientific's client located in the Bothell, WAarea. This position is with a major pharmaceutical company that makes cancer and immunology drugs.If you meet the requirements, please apply to this job and also feel free to follow up via email to Rachita.Saxena@yoh.com. (Job#311801)



6 month W2 contract

2 Positions Available

100% Onsite

-Sun-Wed PM shift (1330-0000) Pay rate: $32.00/hour

-Sun-Wed Grave Shift (2200-0800) Pay rate: $34.50/hour




PURPOSE AND SCOPE OF POSITION:

The Quality Associate 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 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.





REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education: * 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.



Knowledge, Skills, and Abilities

* 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.

Opportunity is Calling, Apply Now!

Recruiter: Rachita Saxena

Rachita.Saxena@yoh.com

What's In It For You?

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

* Medical, Dental & Vision Benefits

* 401K Retirement Saving Plan

* Life & Disability Insurance

* Direct Deposit & weekly ePayroll

* Employee Discount Programs

* Referral Bonus Programs

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!


Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.


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