Responsible for routine calibration for all Laboratory instrumentation. Ensures all instrumentation meets specifications and is properly calibrated.
- Performs routine calibration of the instruments according to the SOPs.
- Ensure calibrated condition of all measurement instruments and measuring devices are operational, reliable and within regulatory compliance. Participate in trouble-shooting process.
- Maintain a state of cGMP Compliance in all activities.
- Act as calibration SME for laboratory instruments.
- Participate in internal and external audits.
- Develop and/or revise calibration procedures and standard operating procedures.
- Review calibration procedures and ensure compliance (vendor’s & internal) and accuracy.
- Maintain Calibration technicians’ training records (obtain from vendors).
- Contact vendor to request services if internally the problems cannot be resolved
- Create the logbooks for maintenance / calibration and special projects
- Archive the calibration records as per the company policies and procedures.
- Perform other related duties as assigned or required
- Report on metrics and appropriately document service on instruments.
- Escort vendors on-site to perform maintenance activities on instruments on contract.
- Other duties as assigned.
- Demonstrate computer literacy with proficiency in Microsoft office software, Trackwise and other data acquisition systems utilized at QC lab.
- Strong organizational skills desired.
- Strong oral and written communication skills, including effective listening.
- Technical ability to problem solve and troubleshoot equipment systems in a pharmaceutical environment, including but not limited to: HPLCs, UPLCs, GCs, Polarimeter, UV-Vis spectrophotometer, FT-IR, Karl Fisher, Stability Chamber, TOCs, Dissolution and Disintegration apparatus, particle size analyzer, melting point apparatus, balance, pH meter and other laboratory equipment.
- Flexibility to work outside of business hours, should issues arise
- Knowledge of Quality systems.
- Must be able to lift up to 40 lbs
- Must be able to ascend/descend a ladder
- Must be able to move about the facility
- Must be able to move in confined spaces
Minimum of Bachelor’s degree in scientific or engineering field.
Minimum of three (3) year experience in a pharmaceutical analytical laboratory.