Metrologist I

4 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time

Job Summary

As a Metrologist I at SUN PHARMA, you will play a critical role in ensuring the accuracy and reliability of laboratory instruments. Your primary responsibilities will include performing or assisting with preventative maintenance, calibration, and qualification of laboratory instruments in accordance with all applicable SOPs to ensure adherence to cGMP in support of the laboratory operation.

Key Responsibilities

  • Develop and implement a master Preventive Maintenance/Calibration schedule to ensure optimal instrument performance.
  • Plan, execute, and review instrument calibration/qualification related activities as per the calibration master plan.
  • Collaborate with cross-functional teams to draft and review instrument operation, maintenance, and calibration procedures.
  • Initiate change controls for new and existing instruments and their procedures.
  • Concurrently document all raw data, observations, and notes in applicable documents.
  • Notify supervisors and management of any anomalous or out-of-control results.
  • Adhere to cGMP and safety procedures to ensure a safe working environment.
  • Review and report any applicable calibration/qualification documents.
  • Log and attend to instrument repair requests in a timely manner.
  • Schedule visits for outside contractors for preventive maintenance or repair.
  • Place "out of service" tags on instruments due for calibration, repair, or new installation.
  • Investigate and conduct primary investigations under direct guidance from management.
  • Ensure adequate labeling of all instruments and maintain accurate calibration status records.
  • Order and maintain spare parts for major instruments to ensure continuous support of analysis.
  • Verify the expiry date of chemicals, reagents, and primary calibrators prior to use.

Work Environment

This role is based in a manufacturing/production/laboratory environment, which may expose you to various environmental factors, including noise, fumes, odors, gases, dust, and hazards.

Physical Requirements

  • Able to lift and carry up to 50 lbs.
  • Frequently required to sit, use hands to handle objects, and reach with hands and arms.
  • Occasionally required to stand, stoop, kneel, and crouch.
  • Specific vision abilities required include close vision, distance vision, color vision, and the ability to adjust focus.

Travel Estimate

Up to 5% travel may be required for this role.

Education and Job Qualifications

  • Minimum BS or equivalent degree in Chemistry or a related discipline.
  • In-depth knowledge of analytical instrumentation, such as HPLC, GC, FTIR, UV, and practical problem-solving skills for instrumentation troubleshooting.
  • Familiarity with ICH and FDA regulatory guidance, 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.
  • Intermediate-B1+ level English language proficiency.

Experience

  • Minimum of two years of Pharmaceutical Industry Laboratory experience.

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