Metrologist
SUN PHARMA · Chattanooga, TN · Today
ManufacturingFull-time
About the role
Perform or assist with all essential tasks including troubleshooting, preventative maintenance, calibration, and qualification of laboratory instruments in accordance with all applicable SOPs to ensure adherence to cGMP in support of laboratory operations.
Responsibilities
- Prepare the master Preventive Maintenance/Calibration schedule.
- Plan, execute, and review instrument calibration/qualification activities as per the calibration master plan.
- Perform troubleshooting of laboratory instruments and ensure they are operational.
- Draft and review instrument operation, maintenance, and calibration procedures.
- Initiate change controls for new and existing instruments and their procedures.
- Author SOPs for new instruments.
- Concurrently document all raw data and observations in notebooks or applicable documents.
- Notify the supervisor of any anomalous or out-of-calibration (OOC) results.
- Notify management of any observations or deviations.
- Adhere to cGMP and safety procedures.
- Review and report applicable calibration/qualification documents.
- Log and attend to instrument repair requests.
- Schedule visits for outside contractors for preventive maintenance or repair.
- Place "out of service" tags on instruments due for calibration, requiring repair, or on new instruments.
- Open investigations 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.
- Provide training and mentoring to less experienced Metrologists, QC Chemists, and Lab Technicians.
- Participate in the CAPEX process and suggest new or replacement instrument requirements for laboratory operations.