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14 days old

Quality Control Associate 1 (Stanford, CA)

Kelly Services
Palo Alto, CA 94301
Quality Control Associate 1

Stanford, CA

Direct-Hire, Full-Benefits


Job Description:

The Quality Control Associate I will perform various routine quality control testing for Microbiological endotoxin, mycoplasma, sterility gram stain testing and sample preparation and biologics flow cytometry, qPCR, etc. assays supporting clinical product manufacturing consistent with principles of current Good Manufacturing Practice cGMP and aligned with the phase of the clinical investigation for treating patients with incurable diseases. This is a full-time, direct-hire role located in Stanford, CA with a schedule of Mon-Fri 9 AM - 5 PM.


Duties include:


+ Perform Microbiology Testing LAL , QC Assays Flow Cytometry, PCR, Sterility, Endotoxin, etc. and prepare samples for sterility testing per test procedures.

+ Adhere to requirements of the method and good documentation practices.

+ Document and maintain environmental monitoring data and generate monitoring reports

+ Document performance of analytical methods in order to be consistent with current GMP and documentation practices.

+ Support document revision/creation in collaboration with PI and QC project lead.

+ Adhere to cGMP compliance requirements to maintain inspection-ready state.

+ Collect, interpret and perform basic analyses and reporting of data from test results.

+ Recommend modifications for optimization or clarification of test procedures, protocols, and assays in collaboration with quality control, quality systems management, Principal Investigator PI and project team.

+ Manage, maintain, monitor, and order QC raw materials and supplies

+ Monitor and troubleshoot pertinent equipment

+ Ensure equipment qualification, preventive maintenance, and calibration are performed per requirement and by due date.

+ Coordinate equipment implementation for use and decommissioning activities.

+ Participate in the investigation of out-of-specification and/or non-conforming test results.

+ Prepare deviation reports per SOPs with input and oversight from supervisor.

+ Implement prevention or corrective actions based on supervisor feedback.

+ Participate in the development and maintenance of QC related SOPs, test procedures, training records, and other QC-related documentation.

+ 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


EDUCATION EXPERIENCE REQUIRED :


+ Bachelor s degree in relevant scientific discipline or other appropriate specialty such as Chemistry, Life Sciences, Engineering and one year related experience or an equivalent combination of education and relevant work experience.


**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** **** **?**


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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-29 Expires: 2022-08-29

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Quality Control Associate 1 (Stanford, CA)

Kelly Services
Palo Alto, CA 94301

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