The Supervisor Metrology is responsible for daily supervision and continuous improvement of the calibration management program for the laboratory instrumentation. Ensures all instrumentation meets specifications and is properly calibrated. Directly assigns and ensures the completion of daily calibration tasks.
- Performs routine calibration of the instruments according to the SOPs.
- Report, document, and investigate any calibration failure.
- Ensure calibrated condition of all measurement instruments and measuring devices are operational, reliable and within regulatory compliance. Participate in trouble-shooting process.
- Work within established spending and capital budgets for department. Identify cost savings.
- Direct Calibration personnel in proper calibration and use of measuring equipment and calibration standards. Review all calibration documentation for thoroughness and accuracy. Maintain state-of-the-art knowledge of instrumentation and calibration practices.
- Maintain a state of cGMP Compliance in all activities. Work closely with Quality Assurance and IT validation departments to ensure strict compliance with GMP guidelines.
- Manage change controls for equipment documents.
- Review / maintain vendor calibration records and other associated documents
- Act as calibration SME for laboratory instruments.
- Participate in internal and external audits.
- Escort vendors on-site to perform maintenance activities on instruments on contract
- Develop and/or revise calibration procedures and standard operating procedures.
- Other duties as assigned.
- Demonstrate computer literacy with proficiency in Microsoft office software, Trackwise and other data acquisition systems.
- Strong oral and written communication skills, including effective listening.
- Knowledge of current industry expectations of validation requirements for equipment validation and qualification.
- Technical ability to problem solved 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
- Able to multi-task productively, well organized, effectively applies time management processes and procedures
- Ability to recognize what needs to be done, taking action, and accomplishing results as the situation demands
- May be required to wear personal protective equipment
- 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
A Bachelors degree is required in Chemistry, Engineering or other technical field of study.
Must have 8 + years of experience working in a laboratory setting, preferably in the pharmaceutical industry including 5+ years of supervisory role.