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Senior Metrologist

Company: Medline Industries, Inc.
Location: Mundelein
Posted on: November 16, 2022

Job Description:

JOB SUMMARY Responsible for evaluating, developing, executing and maintaining calibration and qualification procedures for laboratory equipment and instruments in accordance with cGMP and ISO 17025 regulations. Provide guidance on routine lab equipment purchases and assist with global lab utility system maintenance. MAJOR RESPONSIBILITIES

  • Develop, write, and execute qualification protocols and reports (IQ, OQ, PQ) for routine and specialized laboratory equipment, with knowledge and skill to moderate compliance risk.
  • Develop calibration and preventative maintenance processes and procedures for both routine and specialized laboratory instruments that ensures both reliable instrument performance and appropriate compliance risk.
  • Perform routine and specialized calibration and preventative maintenance events in compliance with written procedures and policies. Review calibration and preventative maintenance data, calibration certificates, and out of calibration investigations for accuracy and compliance.
  • Perform troubleshooting on equipment and lab instruments in order to resolve malfunctions. Proactively develop and evaluate options to address routine/known instrument and equipment issues.
  • Investigate, critically evaluate and review out of calibration events for potential trends and root cause determination. Assist in conducting resulting corrective and prevent actions to address and resolve challenges.
  • Write and review SOPs and training procedures. Participate in laboratory quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs.
  • Provide guidance and training to junior team members, laboratory, divisional team members, and laboratory Managers.
  • Research and recommend options for routine lab equipment purchase.
  • Assist with troubleshooting, maintaining, and refurbishing global lab utilities (i.e. Water system, electrical, HVAC, etc). MINIMUM JOB REQUIREMENTS Education
    • B.A. or B.S. degree in Chemistry, Biology, or Engineering with 4 years of calibration/metrology experience in a regulated environment or High School Diploma or GED with at least 10 years of relevant experience within a regulated environment. Knowledge / Skills / Abilities
      • Capable of standing for long periods of time, lifting up to 50 lbs
      • Proficient with Microsoft programs (Excel, Word, Outlook).
      • Experience with qualifying HPLCs, GCs, stability chambers, face mask testing equipment (i.e. BFE, PFE), and medical device packaging testing for regulated laboratory use. PREFERRED JOB REQUIREMENTS Work Experience
        • Experience working with laboratory software such as LIMS, OpenLab, Blue Hill, etc.
        • System and Facilities requirements for laboratory clean rooms and water systems. COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.

Keywords: Medline Industries, Inc., Arlington Heights , Senior Metrologist, Other , Mundelein, Illinois

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