Quality Control Analyst - Santa Clara - The Planet Group

    The Planet Group
    The Planet Group Santa Clara

    1 day ago

    $48,000 - $82,000 (USD) per year *
    Description

    QC Analyst – (Contract) – Greater Bay Area, CA – Onsite

    Biotechnology company seeks a QC Analyst II for a 10-month long onsite contract opportunity in the Greater Bay area. The ideal candidate will have 2+ years' experience in microbiological, biological, and chemical method execution within GMP regulated environments. This person will be responsible for Environmental Monitoring and Microbiological Testing in GMP aseptic and non-sterile manufacturing cleanrooms to include high-potency API operations. Additionally, they will perform environmental monitoring and utility sampling, while upholding aseptic practices, data integrity (ALCO/ALCOA+), and safety controls for potent compounds. This candidate must have prior experience with aseptic manufacturing principles, pharmaceutical water systems, environmental monitoring programs, and QC laboratory testing experience.

    Benefits

    • Hourly pay of $33/hr. W2 to $40/hr. 1099
    • A long-term contract with potential extensions.

    Requirements

    • BS in Microbiology, Biology, or related pharmaceutical biotechnology area is required.
    • 2+ years of microbiological, biological, and chemical method execution within a GMP environment, including solid cGMP technical training and troubleshooting expertise.
    • Expertise with aseptic manufacturing principles, pharmaceutical water system, and environmental monitoring programs.
    • Prior experience within QC lab testing.
    • Must reside locally and within driving distance to Fremont area client site.
    • Must be willing to be onsite 5 days a week.

    Responsibilities

    • Performing environmental monitoring, sampling, and analysis of production clean zones using particle counters, contact plates, swabs, and microbial air samplers.
    • Performing utility water sampling and testing to include conductivity, TOC, bacterial endotoxins, and bioburden.
    • Performing microbiological testing like microbiological examination, endotoxin, growth promotion and more.
    • Performing sample log-in, assignment of sample tracking number, and coordination of shipment of samples to outside test labs.
    • Performing QC lab testing accurately, according to schooled needs, and as written per procedural documentation. Ensuring all data observations and QC results are accurate.
    • Accurately documenting all data in assay worksheets, lab notebooks, and electronic lab systems (like LIMS) in accordance with ALCO+ data principles and cGMP guidelines.
    • Working independently and collaboratively within the QC department and cross-functional teams.
    • Supporting aseptic process validations and gown certification processes in coordination with manufacturing staff and Quality Assurance.
    • Performing enumeration, characterization, and speciation of microorganisms recovered from samples.
    • Providing ongoing lab maintenance and support in support of cGMP compliance.
    • Responsible for completing/reviewing data packets, test procedures, SOPs, and other controlled documentation in a detailed and accurate manner.
    * This salary range is an estimation made by beBee
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