Temp - Metrologist
Norwich Pharmaceuticals - Norwich, NY
The Metrologist is responsible for all aspects of the QC Laboratory Instrumentation Program. The Metrologist performs or coordinates instrument installation, qualification, repair, troubleshooting, calibration, and maintenance on laboratory equipment, instrumentation, and apparatus.

Organization Structure:

The Metrologist reports to the Manager Quality Control.

Responsibilities:

  • Instrumentation acquisition and installation
  • Source equipment and instrumentation for purchase, and coordinate purchase
  • Author and execute IQ/OQ/PQ protocols in accordance with NPI change control management and validation systems
  • Author SOPs and related documentation for operation/maintenance of equipment
  • Maintain appropriate spare parts inventory
  • Provide training on instrumentation use and maintenance to laboratory analysts
  • Instrumentation calibration,qualification and maintenance
  • Perform or coordinate calibration, qualification and maintenance of laboratory equipment/instrumentation
  • Schedule calibration/maintenance activities of outside vendors and review the work performed by vendors
  • Ensure that equipments are properly tagged with calibration/qualification or not in service status in accordance with NPI SOP
  • Instrumentation repair and troubleshooting
  • Monitor equipment performance throughout lifecycle
  • Apply technical knowledge and experience to return instrumentation to operational state
  • Work with outside vendors to facilitate repairs as needed
  • Provide input to laboratory equipment improvement projects
  • Compliance activities
  • Ensures laboratory equipment and instrumentation are compliant with site and industry standards
  • Perform and document investigations into equipment issues as required by the Quality Investigation System
  • Participate in laboratory investigations as needed
  • Participate in audits as needed
  • Completes corrective and preventive actions assigned by investigations or audit observations
  • Maintains instrument log books
  • Provide SAP equipment resource support
  • Ensure addition of new equipment/instrumentation into SAP Preventive Maintenance System
  • Schedule and track calibration/preventive maintenance activities
  • Maintain accuracy of QC resource inventory and calibration/qualification status in SAP

  • Qualifications:

  • BS in chemistry, physics, metrology, or related field plus 3-5 years of hands-on laboratory experience, or equivalent combination of education and experience
  • Significant experience and expertise in equipment maintenance, repair, electronics, and metrological techniques
  • Excellent oral and written communication skills
  • Proficient in computer use (Word, Excel, PowerPoint, internet) and able to learn new computer applications
  • Ability to comprehend and follow standard operating procedures and test methods
  • Strong analytical aptitude, scientific judgment, and operates with a sense of urgency in a fast-paced environment
  • Strong organization, communication, and interpersonal skills
  • GMP Decision Making Authority :

    Authors, executes, and reviews instrumentation qualification protocols

  • Authors, executes, and reviews calibration and maintenance documentation
  • Authors investigations into non-compliant equipment function
  • Participates in audits as required

  • Norwich Pharma Services - 14 months ago - save job - block
    About this company
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    With a focus on improving patient outcomes, Norwich is a reliable partner for all stages of the product lifecycle. Norwich is a...