Scientist (Instrument Qualification)

Job Description

Job Description

Scientist (Instrument Qualification)

Title : Metrologist

Location : Exton, PA

Reports to : Chemistry, Manufacturing, and Controls (CMC) Analytical Services Manager

Full-time (40 hrs. / week)

Frontage Laboratories Inc. is an award winning, full-service, CRO / Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics / pharmacodynamics (PK / PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position / Job Summary :

Frontage Laboratories, Inc. is hiring an Associate / Mid-Level / Senior Metrologist in CMC Services. The Metrologist provides cGMP analytical laboratory equipment calibration and qualification support, including drafting and execution qualification / validation protocols, instrument calibration, maintenance, and decommissioning.

Roles & Responsibilities :

• Support the BCGT / CMC Labs at Frontage Laboratories, Inc in Exton, PA.
• Calibrate and qualify laboratory instruments to ensure minimal downtime (e.g., HPLC, UPLC, GC, ICP-OES, UV-Vis, FTIR, Stability Chambers, etc.).
• Monitor and schedule the preventative maintenance and calibration of laboratory instrumentation.
• Install and configure new laboratory equipment.
• Monitor equipment failures to determine the need for appropriate remediation.
• Maintain analytical instrument records in accordance with GMP documentation requirements.
• Draft equipment change controls and instrument related deviations.
• Review GMP data related to the qualification of analytical instruments and laboratory equipment.
• Coordinate / interface / host vendors on site.
• Comply with all relevant cGMP regulatory requirements and internal SOPs while conducting assigned tasks.
• Other duties as assigned.

Education, Experience & Skills Required :

Salary and Benefits :

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.