Title: Metrologist (AR&D)
Responsible for the documentation, installation, calibration/verification/qualification, preventive maintenance, and repair of a wide variety of scientific instruments used at AR&D, Frontida Biopharm, Inc., 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 are 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.
- Completes all work in a safe and efficient manner in accordance with cGMP and GLP requirements.
- Maintains and archives calibration/maintenance/service records in Blue Mountain RAM.
- 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 instrumentation 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
Bachelor’s degree in Chemistry or Associate’s degree (A. A.); one to two years related experience and/or training; or equivalent combination of education and experience. Calibration/ Maintenance/Service certifications in lab equipment are preferred. Knowledge/skill/experience in the operation of various laboratory instruments is required. 1-2 years 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. Experience with Blue Mountain RAM is preferred.