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Quality Assurance Associate - cGMP

Kelly Services


Location:
Bothell, WA
Date:
06/06/2018
2018-06-062018-07-05
Job Code:
US15TPJL_BH1442905
Kelly Services
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Job Details

Job Title Quality Assurance Associate - cGMP

Jobid US15TPJL_BH1442905

Location: Bothell, WA, 98021, USA

Description **Kelly Scientific Resources** has a **six-month contract** opportunity for a Quality Assurance (QA) Associate at a Therapeutics company in Bothell, WA. The QA Associate II/III position is an individual contributor role responsible for providing QA oversight of GMP operations including batch record review production and associated cGMP records to assure product quality is consistent with established standards and in compliance with regulatory and industry standards.

**Responsibilities:**


+ Review batch production records, test results, and certificates of analysis.
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 executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
+ Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
+ Act as QA Subject Matter Expert (SME), and support/train cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.
+ Manage 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 approve incoming raw materials, routine preventive and calibration of equipment.
+ Support internal and external audits, including documenting observations and oversee implementation of corresponding CAPAs.
+ Revise Standard operating Procedures as needed. **Qualifications:**


+ 2+ (II) 3+(III) years of experience and knowledge of CGMPs and applicable FDA/EMA regulations in the biotechnology industry; experience in the cellular therapy field is preferred.
+ Hands-on experience with batch record review and product disposition.
+ Detail oriented team player with effective planning, organization and execution skills.
+ Excellent verbal and written communication skills.
+ Strong computer skills with Word and Excel; experience with E-Systems is preferred.
+ Ability to work effectively at a fast pace with cross functional departments.
+ Innovative, proactive, and resourceful; committed to quality and continuous improvement.
+ Ability to anticipate and mitigate challenges.
+ Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
+ **Ability to work in shifts model (4 days x 10 hours) is required including weekends.**
**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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