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Clinical and Health - Scientist I, Formulation

Company: TalentBurst, Inc.
Location: Middletown
Posted on: January 27, 2023

Job Description:

Job Title: Formulation Scientist
Location: Middletown, VA 22645
Duration: 12 months extendable contract

TalentBurst offers comprehensive benefits to temporary employees at a cost, they include healthcare, dental, vision, 401k and any State or Federal mandated time off.

Job Description:

Position summary:

  • Manufactures in-vitro diagnostic products (controls and calibrators) used in the clinical laboratory, following cGMP.
  • Completes associated manufacturing documentation and participates in continuous improvement projects.

    Key responsibilities:

    • Manufacture bulk products and perform testing using chemistry clinical analyzers.
    • Completes manufacturing batch records and MPIs, ensure compliance at all times in accordance with cGMP including GDP.
    • Meet on-time delivery dates for each assigned work order and adhere to production schedule.
    • Review and analyze data.
    • Weighing, transfer, mixing of chemicals required.
    • Initiates non-conformance reports as required.
    • Perform product filtrations.
    • Review and approve completed batch records.
    • Maintain and analyze lot histories for trends and discrepancies.
    • Assist with modifying SOPs, work instructions and reports.
    • Recommends improvements to processes, environment or equipment.
    • Participate in daily/weekly lab '5s' activities.
    • Keep department lead or manager updated on all issues.
    • Monitor stocks of common lab supplies.
    • Perform other job duties as required .

      Minimum Requirements/Qualifications:

      • BS/BA in scientific discipline (chemistry/biochemistry) with 0 - 2 years related experience and/or training preferred.
      • AA degree with 2 - 4 years related experience may be substituted
      • Experience/understanding of Quality System Regulations and cGMP preferred
      • Detail oriented, organized, self-motivated and focused
      • Good verbal and written communication skills
      • Can follow procedures carefully
      • Computer/software skills (Outlook, Excel and Word)
      • Strong laboratory skills including pipetting, safety, and hazardous chemical handling

        Non-negotiable hiring criteria:

        • Basic lab skills and knowledge of safety precautions
        • Must be able to work with potentially hazardous chemicals and human source materials
        • Must be able to walk and/or stand for extended periods of time
        • Must be able to lift 25 lbs routinely.
        • May be required to lift up to 50 lbs occasionally
        • This position has not been approved for Relocation Assistance.

Keywords: TalentBurst, Inc., Germantown , Clinical and Health - Scientist I, Formulation, Healthcare , Middletown, Maryland

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