JobWatch

1+ months

Quality Assurance Associate

Kelly Services
Sunnyvale, CA 94086
**Quality Assurance Specialist**

**Sunnyvale, CA**




Our client has developed state of the art manufacturing processes for innovative cellular therapies. They are scientists, engineers, physicians, support specialists, and more all dedicated to improving scientific understanding and impacting human lives. At the Sunnyvale facility we strive to find solutions to both the technical and conceptual barriers to enable development of cell and gene therapy approaches for the treatment of human disease.



Our client is a company that is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.




**Your Tasks**

As a member of the Quality team, you will have the unique opportunity to support the daily Quality Assurance activities related to GMP manufacturing for cell therapy products. You will have the opportunity to perform compliance review of batch production records and equipment documentation for GMP manufactured clinical products. In addition, you will support the team with routine in-phase inspections during clinical product manufacturing. Furthermore, you will be responsible for authoring, reviewing and revising relevant documentation, performing quality reviews, conducting review of batch production records, conducting investigations, and assisting in hosting audits. The duties of this position will allow you to interact as part of a collaborative team environment. Overall, your keen ability to support the maintenance of quality systems and processes will help power their products and growing success.



**Requirements**




+ B.S. degree in a Life Science

+ Minimum of 2 years direct experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry; or equivalent combination of education and experience.

+ Experience in cell-based therapeutics or biopharmaceuticals

+ Strong knowledge of cGMPs

+ Excellent oral and written communication skills

+ Ability to work evening shift (Monday through Friday from 12:30PM to 9:00PM) with the flexibility to work weekends as needed.

+ Must be authorized to work in the U.S.




**Physical Demands**

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.



**Work Environment**

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.



They are an EO Employer M/F/Veteran/Disability/Sexual Orientation/Gender Identity






**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: 2020-02-07 Expires: 2020-04-09

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Quality Assurance Associate

Kelly Services
Sunnyvale, CA 94086

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