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Lab Metrologist – Chemistry

Location

Charles City, IA, USA

Department

ITQuality Assurance

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Overview

The Lab Metrologist – Chemistry will ensure all laboratory instrumentation and software systems are in a state of regulatory compliance and readiness.

 

Responsibilities

  • Plan, schedule, and monitor laboratory needs to ensure instrumentation is available to support on time testing and delivery.
  • Perform routine instrument preventive maintenance (PM), Calibration (Cal), and Qualification (Qual.) on instruments according to established procedures.
  • Maintain the schedule for instrumentation PM, Cal, and Qual. activities.
  • Perform routine and advanced troubleshooting and repair of laboratory instruments.
  • Review documentation associated with instrument PM, Cal, and Qual. events.
  • Recommend changes to established instrument procedures to improve efficiency while maintaining compliance.
  • Create, maintain, and update documentation and Standard Operating Procedures relating to instrumentation.
  • Administer users and conduct standard configuration within instrument software.
  • Work closely with MIS personnel during performance of job responsibilities.
  • Coordinate service providers to schedule work. Facilitate communication and provide information regarding instrumentation issues or service.  Manage service contracts.
  • Maintain instrument parts inventory system.
  • Provide assistance with internal and external audits.
  • Participate in a scheduled On-Call rotation covering off-hours support of the facility.

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.  All employees are expected to report to work regularly and promptly.  Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications

  • 3 + years’ experience supporting, repairing, troubleshooting and maintaining various analytical instruments. Prior experience with Waters UPLC, Agilent HPLC and Agilent GC equipment will be given preferential consideration.
  • Bachelor’s degree in Chemistry or equivalent education / experience in a specialized laboratory required.   Experience in a contract API manufacturing environment, a plus.
  • Ability to work in a fast-paced highly independent and self-directed work environment.
  • Strong written and verbal communication skills to aide in communicating with peers, internal customers, vendors, and in documentation and procedures.
  • Familiarity GMP regulations is required. Prior experience in a GMP analytical laboratory is preferred. Experience with GAMP a plus.
  • Functional understanding of laboratory instrumentation and computer validation (IQ/OQ/PQ).
  • Hands on operational knowledge of analytical instrumentation like UPLC, HPLC, GC, FT-IR, UV-VIS, DSC, ICP, and titration equipment.
  • Experience with analytical software systems like Waters Empower, Mettler-Toledo LabX, and others. Administrative knowledge a plus.
  • Understanding of basic networking, client-server architectures, and Windows workstation and server operating systems.
  • Skills in basic mathematics and statistical calculations.
  • Demonstrated computer software literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment.