Quality Control Assay Transfer Specialist - Sunnyvale, CA

Quality Control Assay Transfer Specialist, Sunnyvale, CA

Direct Hire

We have an exciting direct hire Quality Control Assay Transfer Specialist opportunity at a biomedical research, cell & gene therapy company in Sunnyvale, CA.

Job Responsibilities:

As a member of the Quality Control team, the candidate will have the opportunity to drive Quality Control activities associated with biological and molecular assay transfer and qualification. QC technician will assist researchers in the initial design of assays. They will then further develop the assay using ICH guidelines as a standard. QC technician will lead the assay transfer from R&D to GMP. QC technician will have an active role in assay qualification and trending program for GMP lot release of cellular products and stability plans for critical reagents and critical standards. Assay development tasks will include identifying appropriate controls, standards and criteria for a valid assay, while qualification tasks will include writing, executing, and reporting qualification activities. Overall, your exceptional skills, assay knowledge, and understanding of quality control will champion the continued development of company’s products and growing success.

Experience/Skills:

  • M.S. or PhD in the life sciences or a similar area of study and 5 years of related industry experience and/or training in biological and molecular assay methodology; or equivalent combination of education and experience.
  • Experience with, but not limited to, plate readers, qPCR instrumentation, flow cytometry and cell based assays.
  • Strong knowledge of quality compliance (GMP, ICH, FDA, EP, and USP policies/guidelines).
  • Thorough understanding of analytical bio-assays, including assay transfer qualification, validation, maintenance, and statistics

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 20 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.

For immediate consideration, please email sayn914@kellyservices.com

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 relevant projects. Our connections can lead you to innovative scientific pursuits you’ll 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 career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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