30 days old

Quality Control Specialist For Leading University's Lab Affiliate

Kelly Services
Palo Alto, CA 94301
**Job Summary**

Cell and Gene Therapy Lab affiliate of well-known Northern California University is seeking seeking a Quality Control Specialist to design, develop, evaluate and implement quality control testing, assays and procedures for clinical materials manufacturing consistent with principles of current Good Manufacturing Practice cGMP to support phase appropriate clinical investigation s for treating patients with incurable diseases.

Functioning as a GMP multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Children s Hospital LPCH and University Health Care in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.

This is a growing, dynamic team, dedicated to supporting translational medicine and contributing to the University's Medicine s mission.

**Responsibilities include:**

+ Evaluate, 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 at Laboratory for Cell and Gene Medicine.

+ 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 PI's, lab team, clinical team.

+ 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

**Our ideal candidate will have:**

+ Bachelors of Science Degree in relevant field

+ Experience with PCR, Flow Cytometry and GMP

+ 2-3 years experience in a Quality Control role in pharma, biotech, GMP lab setting

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**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 (plus, did we mention we provide a ton of benefits ?). 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. (
Posted: 2021-05-14 Expires: 2021-06-14

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Quality Control Specialist For Leading University's Lab Affiliate

Kelly Services
Palo Alto, CA 94301

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