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- Palo Alto, CA 94303
- Sara Anvari
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Quality Control Specialist
Kelly Scientific Resources • Palo Alto, CA
Posted 1 month ago
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Quality Control Specialist, Palo Alto, CA •**Must have GMP experience Direct Hire opportunity
- Evaluate, develop and perform complex chemical, biochemical, biological and/or microbiological testing, assays and procedures related to quality control QC , which constitute the quality, safety and efficacy of all analytical methods for clinical materials manufactured
- Develop and perform tests related to assays/analytical methods; collect, interpret, analyze and report data related to test results including investigation of out-of-specification and/or non-conforming test results.
- Perform analytical method, analyze collected data, and determine specifications for each test method.
- Evaluate proposed specification changes and escalate to Functional Manager.
- Present data to stakeholders
- Perform and document assay qualification as applicable per regulation requirements.
- Document execution of test methods according to test procedure, GMP, and good documentation requirements.
- Manage materials/supplies related to clinical materials manufacturing.
- Create selection criteria, justification and qualification of raw materials as it relates to assay development.
- Responsible for examining and documenting materials used in clinical materials quality control testing, consistent with defined, relevant quality standards and cGMP.
- Participate in the evaluation of suppliers/contract testing lab including, but not limited to, analyzing test methods and establishing contract with supplier/vendor as applicable.
- Resolve issues associated with vendor/supplier and changes/deviations to the generation of materials/reagent.
- Ensure equipment qualification, preventive maintenance, and calibration are performed per requirement and by due date.
- Coordinate equipment implementation for use and decommissioning activities.
- Investigate out-of-specification and/or non-conforming test results.
- Initiate, investigate as appropriate, and prepare deviation reports for SOPs and test methods with input from supervisor in order to implement prevention or corrective actions.
- Perform QC Support tasks e.g. equipment maintenance, tracking of reagent and sample inventory, organization of the lab, checking to ensure removal of expired media performed, etc. Coordinate the timely shipment of samples to contract laboratory for testing e.g. ship samples such as environmental monitoring plates for growth promotion, speciation and product sample . –
- Bachelor’s degree in relevant scientific discipline or other appropriate specialty such as Chemistry, Life Sciences, Biochemical Engineering) and three years’ experience or an equivalent combination of education and relevant work experience.
- Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.
- Flexibility to support changing priorities while maintaining collaborative approach and cGMP compliance.
- Able to work independently with some supervision, propose recommendations and solutions regarding development and execution of QC assays.
- 3-5 years cGMP experience.
- Experience with Cell Culture and flow cytometry, qPCR, sterility testing, and/or environmental monitoring activities.
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 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 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.
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 connect with 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 is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.