Scientist (Instrument Qualification)

ZipRecruiter; Exton (Chester County); On-site; USD 60,000 - 85,000; Full time

Job summary

A leading contract research organization is seeking a Metrologist to join their team in Exton, PA. The role involves calibrating and qualifying laboratory instruments, ensuring compliance with regulatory requirements, and maintaining analytical instrument records. Ideal candidates will possess a relevant Bachelor's degree and experience in a regulated industry.

Benefits

Health and dental insurance

401(k) plan

Life insurance

Qualifications

• Experience in a regulated pharmaceutical or related industry.
• Working knowledge of laboratory instruments and calibration.
• Ability to draft and execute qualification/validation protocols.

Responsibilities

• Calibrate and qualify laboratory instruments to ensure minimal downtime.
• Monitor and schedule preventative maintenance of laboratory instruments.
• Ensure compliance with cGMP regulatory requirements.

Skills

Organizational skills

Communication skills

Education

Bachelor’s degree in a relevant scientific, engineering, or computer-based field

Tools

Microsoft Office

Job description

Job Title: Metrologist

Location: Exton, PA

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

Employment Type: 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 Summary:

We are hiring an Associate/Mid-Level/Senior Metrologist in CMC Services. The Metrologist will provide cGMP analytical laboratory equipment calibration and qualification support, including drafting and executing qualification/validation protocols, instrument calibration, maintenance, and decommissioning.

Responsibilities:

1. Support the BCGT/CMC Labs at Frontage Laboratories, Inc in Exton, PA.
2. Calibrate and qualify laboratory instruments (e.g., HPLC, UPLC, GC, ICP-OES, UV-Vis, FTIR, Stability Chambers) to ensure minimal downtime.
3. Monitor and schedule preventative maintenance and calibration of laboratory instruments.
4. Install and configure new laboratory equipment.
5. Monitor equipment failures to determine necessary remediation.
6. Maintain analytical instrument records according to GMP documentation requirements.
7. Draft equipment change controls and instrument-related deviations.
8. Review GMP data related to the qualification of analytical instruments and laboratory equipment.
9. Coordinate with vendors on-site.
10. Ensure compliance with all relevant cGMP regulatory requirements and internal SOPs.
11. Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in a relevant scientific, engineering, or computer-based field.
• Experience in a regulated pharmaceutical or related industry (level dependent).
• Working knowledge of Microsoft Office applications.
• Excellent organizational and communication skills.

Salary & Benefits:

We offer a competitive compensation and benefits package, including health and dental insurance, a 401(k) plan, insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or veteran status.