Laboratory Metrologist

About This Role

The Laboratory Metrologist is responsible for performing routine and non-routine calibrations and maintenance for equipment in the Analytical Laboratory in compliance with cGMP, FDA and other regulatory requirements. This role also involves creation and execution of instrument qualification with support.

Responsibilities

• Perform maintenance and calibrations for intermediate laboratory instruments (e.g. HPLC, UPLC, GC)
• Act as subject matter expert for operation and troubleshooting of intermediate laboratory instruments
• Assess impact and provide recommendations for requested changes (Change Control) in qualified laboratory instruments with support
• Support and maintain the qualified state of laboratory instruments in compliance with USL, FDA and other regulatory requirements
• Write and execute qualification documents (IQ/OQ/PQ, etc.) and technical reports with support
• Participate on project teams
• Author deviations with support
• Prioritize workload independently and tracks completion of high priority activities
• Plan maintenance and calibration activities around lab testing activities and be willing to shift priorities to meet business needs
• Ensure that tasks performed are consistent with company policies and Code of Conduct
• Correspond with outside vendors, compendial groups (USP, ICH, etc.) and other departments with minimal supervision
• Review and revise SOPs used for instrument operation/maintenance/calibration
• Manage project timelines with support and notify management if deadlines will not be met
• Provide leadership and training for junior calibration technicians

Requirements

• Experience in calibrating and maintaining HPLC, GC, IR, AA, and UV and other laboratory equipment
• Intermediate understanding of USP chapters related to calibration and qualification of equipment
• Strong verbal and written communication skills
• Ability to work independently and with others and to multi-task
• Experience or training in Word or Excel and other computer software

Qualifications

• Bachelor's Degree in Chemistry, Engineering or related field or Master's Degree or High School Diploma or equivalent
• Minimum of 4 years' experience, in calibrating and maintaining HPLC, GC, IR, AA, and UV and other laboratory equipment, preferably in the pharmaceutical industry (if Bachelor's Degree) or minimum of 2 years' experience (if Master's Degree) or 10 years working in a lab setting with 4 years maintaining/calibrating equipment (if High School Diploma)

Nice to Have

• Experience in the pharmaceutical industry

Skills

* Required skills