Oxford Immunotec, Inc.

  • Validation Specialist

    Job Location US-TN-Memphis
    Posted Date 1 month ago(1 month ago)
    ID
    2018-1951
    # of Openings
    1
    Department
    Operations
  • Overview

    The Laboratory Validation Technologist assists the Automation Engineer with the validation and verification of new equipment and processes in the laboratory. The Validation Technologist also assists in the transfer of newly developed assays from the development stage to routine practice in the laboratory in a manner that is consistent with the goals of Oxford Diagnostic Laboratories and with the Quality Management System. Critical to the role is ensuring compliance with regulatory standards, laws and requirements of requisite agencies by employing appropriate systems/processes.

    Responsibilities

    • Assists in the design and testing/implementation of new equipment validations/verifications in the laboratory to include drafting validation protocols and reports consistent with company and regulatory standards.
    • Create, consult, and contribute to the criteria and selection of equipment and processes to facilitate the automation of all laboratory testing.
    • Facilitate the transfer of Projects from Research and Development to commercial testing which may include drafting/authoring appropriate SOPs and training checklists.
    • Maintains competency in Lab Ops in order to assist commercial testing as assigned. Assist with training new employees according to a developed training program
    • Collate clinical test data from diverse sources and conduct data queries from clinical test data. Cross-check the quality of data queries against individual test records
    • Responsible for the execution of instrument correlations.
    • Assist in process improvement projects in varying capacities (project dependent)
    • Assist the manufacturing department in the validation of new product.
    • Assists in research and development projects as necessary.
    • Perform administrative duties related to the general requirements of operation.(e.g. lab stock management, market research/admin related to existing ODL cost and cost reduction of goods and services, contact with suppliers).
    • Participates in the investigation of non-conformances and CAPA planning.
    • Follows all corporate policies and procedures including Safety within the work area.
    • Completes special duties as assigned by the Management team.

    Qualifications

    • Bachelor's degree in Science including up to one year of practical training and one year of full time clinical laboratory experience.
    • At least 1 year of experience with equipment and process validations.
    • Demonstrate flexibility in work schedule when required for successful project completion.
    • Ability to work independently and demonstrate a high degree of personal & professional initiative
    • Problem solving ability - able to develop creative, practical solutions that meet business objectives
    • Strong project management skills ability to create, adapt and follow work plans
    • Ability to work in a global, multicultural collaborative team environment
    • Ability to create cross-functional teams driven by project / business needs; ability to lead teams and secure outcomes without direct line authority
    • Organizational/time management; able to manage multiple competing priorities simultaneously
    • Excellent verbal and written communication skills

    PHYSICAL DEMANDS: 

    The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.

    • Must be able to remain in a stationary position 50% of the time.
    • Occasionally moves about inside the office to access file cabinets, office machinery, etc.
    • Frequently moves equipment weighing up to 50 pounds
    • Job requires employee to sit for extended periods of time without being able to leave the work area.
    • Job requires employee to walk considerable distances in the facility during the course of his or her work.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed