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QC Associate II (Bothell, WA)

Bothell, WA
Since 2001 Hansell Tierney has been one of the premier staffing and recruiting companies in Seattle Washington. As a Certified Women’s Business Enterprise (WBE), Hansell Tierney was created to serve and staff Northwest companies by doing things the right way, not just the easiest. We strive to do better by partnering with candidates, treating your experience as one of our own, providing our candidates with interesting local opportunities, and handling every relationship with the highest level of customer service possible. Our business is built on the deep understanding of the job market and the ability to over-deliver on our promises.


We are currently helping our client, a Seattle-based biopharmaceutical with a search for a Quality Control Associate II. 

Duration - 12 month contract; potential for extension &/or FTE conversion
Location - Bothell, WA
ShiftWED through SAT; 1:30pm to Midnight; 40 Hrs/Week 
Work sponsorship is not available at this time

JOB SUMMARY:
The primary focus of the QC Associate II role will be to perform GMP testing to support product lot release and in-process testing. Additionally, this role will provide technical support and troubleshooting for PCR based testing. 

PRIMARY RESPONSIBILITIES: 
• Perform GMP lot release testing for PCR based test methods and perform data analysis using various software packages. 
• Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports. 
• Assist in the implementation of new assay methodologies and the associated instrumentation. 
• Maintain instrumentation and supporting documentation in a GMP compliant manner. 
• Perform standard preparation and qualification activities. 
• Author test methods and SOP. 

REQUIRED QUALIFICATIONS: 
• Sound understanding and knowledge of PCR based assays as performed in a commercial GMP QC laboratory. 
• Experience with QuantStudio and Gen5 data analysis software is a plus; or similar software. 
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects. 
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others. 
• Computer proficiency as well as strong scientific and organizational skills. 
• Ability to maintain flexible intellect and adjust to a dynamic work environment. 
• Experience working in a regulated (GxP) environment within defined Quality Systems. 
• Demonstrated success working in a high-performing, business results-driven environment. 

EDUCATION REQUIREMENTS: 
• BS in a scientific discipline with 3+ years of regulated industrial analytical testing or QC experience, or equivalent combination of education and experience.
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