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    Quality Control Technician - Durham, United States - Medasource

    Medasource
    Medasource Durham, United States

    3 weeks ago

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    Description

    Title: QC Environmental Monitoring Technician

    Duration: 612-month contract

    Location: Durham, NC

    • First and second shift work may be required.
    • 12 hour shifts on 2-2-3 schedule
    • Minimal travel required.
    • Some allergens are present in the parenteral plant.

    Summary:

    • The QC Environmental Monitoring Technician will perform routine and investigational environmental monitoring of classified manufacturing, filling, and support areas. Support daily EM laboratory operations.

    Responsibilities:

    • Support production operations by means of EM sampling of classified manufacturing, filling, and support areas and operations personnel.
    • Support daily EM laboratory operations and process/equipment qualification activities, as necessary.
    • Ensures compliance with current Good Manufacturing Practice (cGMP) and maintain constant inspection-readiness.
    • Ensures that data-integrity is maintained
    • Participate in process streamlining and continuous performance improvement.
    • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
    • EM Technician requires gowning certification, and repeatedly aseptically gown daily.

    Requirements:

    • High School Diploma or equivalent, Associates degree preferred.
    • Understanding of cGMP
    • Excellent written and oral communication skills and ability to collaborate and interact with a team.
    • Work in a dynamic and fast paced environment with potential to work shifts and weekends.
    • Must be able to lift 30 pounds and be able to pass, push, and pull to execute specific aspects of job duty.
    • Must be able to stand / walk for extended periods of time.

    Preferred Qualifications:

    • Environmental Monitoring experience preferred.
    • Manufacturing or production experience preferred.
    • Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.
    • Technical writing and written communication skills are a plus.
    • Understanding of regulatory standards / requirements for EM.
    • Knowledge of / familiarity with Parenteral production environments and operations.
    • Strong computer skills, documentation skills, and attention to detail.
    • Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
    • Ability to focus on continuous improvement.
    • Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.
    • Understanding of compliance requirements and regulatory expectations for lab systems.
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