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Metrologist/Instrumentation Specialist

Location

High Point, NC, USA

Department

Analytical Support

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

The Metrologist/Instrumentation Specialist will be responsible for ensuring all laboratory instrumentation and associated 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.
  • Act as an escort for the approved vendors performing required external calibration and review calibration notebooks per applicable SOPs/procedures
  • 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.

 

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 HPCL and GC equipment will be give high preferential consideration.
  • Bachelor’s of Science degree in Chemistry or equivalent specialized laboratory experience 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.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.