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Quality Control Specialist (Cell Therapy, Biological Science) - Palo Alto, CA

Kelly Services
Palo Alto, CA 94301
Quality Control Specialist (Cell Therapy, Biological Science), Palo Alto, CA



**Direct Hire Opportunity**



****MUST HAVE: Experience in cell culture, flow cytometry and environmental monitoring**



This position will join the Laboratory for Cell and Gene Medicine (LCGM) 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.



LCGM is a GMP multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support 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.



LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contribution.



**Duties include:**




+ 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 at Laboratory for Cell and Gene Medicine (LCGM).

+ 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 (PIs, LCGM 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 laboratory for testing (e.g. ship samples such as environmental monitoring plates for growth promotion, speciation and product sample).

+ Other duties may also be assigned



DESIRED QUALIFICATIONS:




+ 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 activities, Flow Cytometry, qPCR, Sterility testing, and/or Environmental Monitoring activities





EDUCATION & EXPERIENCE (REQUIRED):




+ Bachelors degree in relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, Biochemical Engineering, or Engineering) and three years

+ Experience or an equivalent combination of education and relevant work experience



KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):




+ Applicable or related experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.

+ Strong analytical technical skills and experience with testing QC methods and concepts.

+ Good understanding of cGMP or International Organization for Standardization (ISO) requirements, quality systems.

+ Strong team-oriented, interpersonal skills and collaborative work style.

+ Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.

+ Excellent organizational skills and attention to detail.

+ Excellent verbal and written communication skills.



**_For immediate consideration , apply today!_**








**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

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Posted: 2020-01-13 Expires: 2020-02-13

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Quality Control Specialist (Cell Therapy, Biological Science) - Palo Alto, CA

Kelly Services
Palo Alto, CA 94301

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