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20 days old

Quality Control Associate II (Stanford, CA)

Kelly Services
Palo Alto, CA 94301
**Quality Control Associate II (QC II)**

**Stanford, CA**

**Direct-Hire, Full-Benefits**


**Job Summary:**

The Quality Control Specialist is responsible for designing, developing, evaluating and implementing 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. This is a full-time, direct-hire role located in Stanford, CA with a schedule of Mon-Fri 8 AM - 5 PM with occasional off-shift flexibility.


**Essential Duties:**


+ 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).


**Job Requirements:**


+ 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.

+ 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.

+ 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.


\#P1


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-09 Expires: 2022-10-10

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Quality Control Associate II (Stanford, CA)

Kelly Services
Palo Alto, CA 94301

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