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    Clinical Laboratory Lead - Miami, FL, United States - Quotient Sciences Limited

    Quotient Sciences Limited
    Quotient Sciences Limited Miami, FL, United States

    2 weeks ago

    Default job background
    Description

    Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and money in getting drugs to patients.

    As a growing and successful business, we employ more than 1,100talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.

    People join Quotient Sciences because we are a respected member of the drug development communitythat's focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

    The Role

    • Overall responsibility for quality of laboratory processing for assigned duties
    • To ensure study data is collected to a high quality in accordance with ICH-GCP, protocol and lab manual
    • To ensure subject safety at all times

    Main tasks and responsibilities

    • Provides encouragement, support, positive reinforcement to laboratory technicians
    • Oversees sample labelling, processing and shipping duties as required
    • Ensures lab set up and cleaning duties are performed on a daily, weekly and monthly basis
    • Processes biological samples as per lab manual when required
    • Attends all pre-study meetings, including SIVs and protocol trainings for assigned studies
    • Reviews/Approves lab manual prior to the start of a study
    • Ensures sample shipments are organized and sent to clients as per the lab manual and study timeline
    • Ensures sample shipment checklists and sample manifests are generated and reviewed for all sample shipments
    • Performs sample processing checks on all studies to ensure compliance with lab manual and SOPs
    • Ensures the QC of laboratory source data and performs QC as necessary
    • Works in a safe and responsible manner at all times
    • Reviews protocol specimen processing requirements and ensures that an adequate inventory of necessary supplies are available or ordered and delivered prior to study start and throughout study conduct
    • Reviews/approves specimen labels prior to tube preparation
    • Ensures collection tubes and freezer vials are properly labelled and set up prior to scheduled sample collection
    • Processes samples and assists with laboratory duties as needed
    • Assists with SOP reviews and edits
    • Works with Data Entry team to resolve discrepancies/queries noted during lab tracking or monitoring visits
    • Assists with training of new laboratory staff and ensures lab staff are fully trained and signed off in the relevant SOP/competency and protocols before working unsupervised or on a study

    Additional Tasks/responsibilities

    • May serve as a backup to the Clinical Laboratory Manager when required

    The Candidate

    • Education or equivalent experience in a science, health or customer related field
    • Supervisory experience preferred
    Application Requirements When applying for a position with Quotient Sciences you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
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