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    Lab Ops Specialist I - Santa Monica, United States - LanceSoft

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    Description
    Lab Ops Specialist I

    Location:
    On-site @Santa Monica at RDMC Location.

    Hours/Days:
    (Tuesday-Sat) Flexible hours.

    Everyone is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.


    We are seeking a highly motivated individual to join us as a Lab Ops Specialist I in Quality Control Sample Management in Santa Monica, CA.

    Responsibilities


    • Perform QC sample receipt, processing and distribution for testing and storage
    • Perform Apheresis Accession, Inspection, and assist QA with product returns
    • Maintain, operate equipment and instruments supporting sample processing
    • Work with internal resources to maintain lab in an optimal state
    • Perform Cryo sample disposition and shipment
    • Track inventory of lab supplies and materials
    • Track inventory of retain samples, stability samples, test materials
    • Track and distribute samples according to Stability protocols
    • Troubleshoot standard issues and identify when a deviation from standard process occurs
    • Gather metric information for use in continuous improvement of areas of responsibility
    • Data entry and review
    • Support generation of CoAs for product release
    • Revise and review SOPs, work-instructions, forms, sampling plans
    • Monitor the GMP systems currently in place to ensure compliance with documented policies
    • Assist with audits, walkthroughs, inspections, when necessary
    • Additional duties as assigned
    Basic Qualifications


    • Bachelor's Degree OR
    • Degree and 1+ years of experience in Quality Control/GMP Environment OR
    • High School Degree and 3+ years' experience in Quality Control/GMP Environment

    Physical requirements:
    Ability to lift up to 30 lbs

    Preferred Qualifications


    • Degree in biotechnology or related field with Quality Control experience
    • Working knowledge of GMP, SOPs and quality control processes
    • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
    • Proficient in MS Word, Excel, Power Point and other applications
    • Ability to communicate and work independently with scientific/technical personnel
    • Strong written and verbal communication skills
    • Comfortable in a fast-paced small company environment with direction and able to adjust workload based upon changing priorities
    • Experience with LIMS
    • Ability to work with a variable schedule

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