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30 days old

Quality Assurance Investigator- Bothell, WA

Kelly Services
Bothell, WA 98021
**Quality Assurance Investigator (Therapeutics Industry)**



**Bothell, WA**



**Temp to Hire (Day Shift)**





This role is responsible for leading deviation investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SME s and determine the associated corrective action to prevent the deviation from recurring. .




**Responsibilities**

Responsible for the Quality Assurance GMP deviation investigation lead

Provide consistent direction and ensure timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspections.

Develop a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.

Develop the necessary skills using the appropriate tool(s) and statistical application in risk management and Root Cause Analysis to enable the effective and timely close of deviation investigations.

Provide consistent oversight and recommendation of quality product disposition according to the results of the investigation.

Collaborate with stakeholders and management, and communicate investigation status to management as appropriate.

Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management systems.

Develop individual goals and ensure the timely completion of all deliverables.

Champion and foster a positive and successful collaborative quality culture, aligned with Junos existing culture.

Act as subject matter expert for QA oversight of GMP deviation investigations during regulatory inspections.




**Requirements**

BS/MS in relevant Science or Engineering discipline and 5+ years of experience in execution of deviation investigations.

Experience in Quality Assurance function or technical Manufacturing Science and Technology (MSAT) role in a GMP manufacturing operation.

Expertise in GMP compliance and FDA/EMA regulations.

Background in Protein Biologics or Cell Therapy Manufacturing is required

Demonstrated excellence in written and verbal communication

Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


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




**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: 2019-10-18 Expires: 2019-11-18

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Quality Assurance Investigator- Bothell, WA

Kelly Services
Bothell, WA 98021

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