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.