|| Sr. Metrology Analyst
Responsible for the documentation, installation, calibration/verification/qualification, preventive maintenance, and repair of a wide variety of scientific instruments used at Frontida BioPharm, including but not limited to: HPLC, UPLC, GC, UV/Vis, FTIR, dissolution, particle size analyzers, etc.
- Calibrates/verifies/qualifies and performs preventative maintenance on laboratory equipment which include, but is not limited to, HPLC, UPLC, UV/Vis, GC, dissolution, FTIR, particle size analyzers, etc.
- Inspects, evaluates, troubleshoots, and repairs laboratory equipment when problems arise.
- Documents, reviews, and audits calibration/maintenance/repair activities of laboratory equipment.
- Maintains calibration/maintenance schedules to keep the Calibration Program up-to-date through the Computerized Maintenance Management System (Blue Mountain Regulatory Asset Manager).
- Completes all work in a safe and efficient manner in accordance with cGMP and GLP requirements.
- Maintains and archives calibration/maintenance/service records.
- Assists in the installation, operation, and performance qualification (IQ/OQ/PQ) of laboratory instruments.
- Installs/re-installs, disassembles, cleans and makes necessary modifications to various instruments.
- Records and reports out-of-tolerance results and any other instrument-related issues to the manager and performs corrective actions as directed.
- Arranges for vendor service when necessary.
- Maintains inventory and researches options on prices and availability of parts.
- Works closely with users and external groups to help operate and develop techniques that will meet the needs of the user community.
- Participates in writing SOPs, protocols, and instrument validation plans.
- Aids in laboratory investigations due to instrument-related issues when needed.
- Explores ways that maximize efficiency at lower costs.
- Must participate and successfully complete all company training, as required.
- Performs other duties as assigned.
|Knowledge and Skills
Associate’s degree (A. A.) or equivalent from technical school; two to four years related experience and/or training; or equivalent combination of education and experience. Bachelor’s degree in Engineering or Chemistry is preferred. Calibration/Maintenance/Service certifications in lab equipment are required. Extensive Calibration/Maintenance/Repair experience on various lab instruments required. Minimum 2 – 4 years experience of HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR and/or Particle Size Analyzer calibration, maintenance, and/or repair experience is preferred. Previous experience in the pharmaceutical industry highly desirable. Must have good communication and technical writing skills. Proficiency in Microsoft Word, Excel, and Outlook and the ability to learn other software applications, as required.