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    Bioanalytical Sample Operations Lead - Germantown, United States - AMADOR BIOSCIENCE INC

    AMADOR BIOSCIENCE INC
    AMADOR BIOSCIENCE INC Germantown, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    Overall Responsibilities:

    This position is responsible for performing all assigned and routine document related tasks in accordance with Company SOPs and relevant regulatory requirements to include Good Laboratory Practices (GLPs) & Good Clinical Practices (GCPs).

    Sample Operations Responsibilities:

    • Lead and participate in bio-specimen accessioning and ordering with our internal stakeholders.
    • Prior experience with Watson LIMS (or comparable LIMS) Sample Handling module.
    • Establish robust procedures to ensure shipment and tracking of biospecimen shipment through WATSON LIMS and specimen storage.
    • Ensure delivery and tracking of biospecimen shipments.
    • Prepare sample storage notification forms for clients.
    • Receive, log in, and meticulously track biological samples, reference standards, and chemicals in strict accordance with Standard Operating Procedures (SOPs) and/or Policies or Work Instruction documents.
    • Manage the specimen storage at the appropriate temperature and location in appropriate storage units.
    • Manage short- and long-term maintenance responsibilities of all sample storage units in accordance with SOPs and other critical documentation.
    • Prepare specimens for technical staff for testing according to schedule and testing plans for the workday/workweek.
    • Make recommendations for the implementation of strategic lab operation objectives.
    • Support the BABM unit with the implementation of new technical resources to improve clinical specimen storage through WATSON LIMS.
    • Maintain compliance with regulations and SOPs.
    • Participate in the Laboratory workflow daily, including quality control on instruments, schedule maintenance with vendors upon needs.
    • Acting as a liaison between leadership staff and key stakeholders.
    • Actively participate in the cleansing, sanitizing, and maintaining of lab equipment according to appropriate policies and Laboratory SOPs.
    • Communicate with clients regarding sample disposal in accordance with SOPs or directives from clients.

    Clinical Kitting Responsibilities:

    • Prepare clinical sample collection kits per Standard Operating procedures and/or Laboratory Manuals.
    • Assemble and label kit components, including collection tubes, vials, documentation, and boxes per specific kit assembly instructions.
    • Aliquot reagents using specific aseptic techniques.
    • Communicate to client points of contact in relation to kit components.
    • Complete and track batch records and supporting documentation.
    • Report discrepancies to assigned leadership staff.

    Qualifications:

    • Bachelor's degree, preferably in the chemical or biological sciences. Other degree majors can be considered in combination with an applicable experience base.
    • Must be able to complete all forms legibly and accurately and/or notebooks.
    • Experience in applying Good Laboratory Practice (GLP) and/or Good Documentation Practice (GDP) standards is a plus.
    • Must be able to attain proficiency in using company database applications required for the completion of assigned tasks.

    PHYSICAL REQUIREMENTS:

    • This position requires working around and with biohazardous human and animal blood products and strict adherence to the use of Personal Protective Equipment (PPE).
    • This position requires working in a dynamic laboratory environment and coordinating your activities with the activities of other laboratory personnel. In rare occasions during situations of unusually heavy workload or fast turnaround requirements, overtime on weekdays and/or weekends may be assigned.
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