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Metrologist

4 months ago

New Brunswick, United States ProStaff Workforce Solutions Full time

Onsite

Direct Hire

Direct HireJob Summary:

Perform or assist with all essential tasks including preventative maintenance, calibration, and qualification of laboratory instruments in accordance to all applicable SOP to ensure adherence to cGMP in support of the laboratory operation. Assist with instrument maintenance and schedule outside contractor where necessary.

Essential Job Functions:

  • Preparation of master Preventive Maintenance/Calibration schedule.
  • Plan, execute, and review instrument calibration/qualification and related activities per calibration master plan.
  • Draft and review of instrument operation, maintenance and calibration procedures.
  • Initiate change controls for new and existing instrument and its procedures.
  • Prepare documentation of all raw data/observations.
  • Notify supervisor of any anomalous or OOC results. Notify management of any observations or deviations.
  • Adhere to cGMP and safety procedures.
  • Review and report any applicable calibration/qualification documents.
  • Logging and attending instrument repair requests.
  • Scheduling visit for outside contractors for preventive maintenance or repair.
  • Tag instruments due for calibration and/or repair.
  • Open and conduct primary investigations under direct guidance from management.
  • Ensure adequate labeling of all instruments and ensure instrument calibration status.
  • Order and maintain spare parts for major instruments to ensure continuous analysis support. Verify the expiry date of chemicals, reagents, primary calibrators prior to use.

Requirements and Qualifications:

  • Minimum BS or equivalent degree in Chemistry or related discipline
  • Minimum of four (4) years of Pharmaceutical Industry Laboratory experience
  • In depth knowledge of analytical instrumentation such as HPLC, GC, FTIR, UV and practice.
  • Practical problem-solving skills for instrumentation troubleshooting.
  • Familiar with lab software’s and requirements for their qualification/validation.
  • Knowledge of ICH and FDA regulatory guidance.
  • Must be familiar with cGMP/GLP practices for analytical laboratories and EHS/OSHA safety regulations.
  • Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
  • A self-starter with a hands-on approach and a can-do attitude.
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
  • Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.