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Metrologist I

2 months ago


Fredericton, New Brunswick, Canada SUN PHARMA Full time

Job Summary

We are seeking a highly skilled Metrologist I to join our team at SUN PHARMA. As a key member of our laboratory operations, you will be responsible for performing and assisting with all essential tasks related to the calibration, qualification, and maintenance of laboratory instruments.

Key Responsibilities

  • Develop and implement a master Preventive Maintenance/Calibration schedule to ensure adherence to cGMP.
  • Plan, execute, and review instrument calibration/qualification activities as per the calibration master plan.
  • 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 applicable documents.
  • Notify supervisors and management of any anomalous or out-of-control results.
  • Adhere to cGMP and safety procedures.
  • Review and report applicable calibration/qualification documents.
  • Log and attend instrument repair requests.
  • 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 their calibration status.
  • 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.

Education and 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 practice.
  • Practical problem-solving skills for instrumentation troubleshooting.
  • Knowledge of ICH and FDA regulatory guidance.
  • Familiarity 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.
  • Intermediate-B1+ level English language proficiency.

Experience

  • Minimum of two years of Pharmaceutical Industry Laboratory experience.