Instrument Qualification Specialist in CMC Services

Title: Instrument Qualification Specialist

Location: Exton, PA

Reports to: Compliance Manager in CMC Analytical Services

Full-time (40 hrs./week)

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, and growing over 30% YOY. 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:

The Instrument Qualification Specialist provides cGMP analytical laboratory equipment qualification support, including drafting and execution of IQ/OQ/PQ protocols, routine calibration, decommissioning, and software validation in Frontage’s Chemistry, Manufacturing, and Controls (CMC) business unit.

Roles & Responsibilities:

• Efficiently calibrate and qualify analytical instruments and laboratory equipment to ensure minimal downtime (e.g., HPLC, UPLC, GC, ICP-OES, UV-Vis, Stability Chambers, etc.).
• Work with SMEs and Management in establishment of programs and procedures for new equipment, and updating established programs, as needed (e.g., Stability chamber temperature mapping, etc.).
• Install and configure new analytical instrumentation and laboratory equipment.
• Monitor equipment failures to determine the need for appropriate remediation.
• Maintain analytical instruments and laboratory equipment records in accordance with GMP documentation standards.
• Author qualification protocols and change controls specific to qualification and/or validation of analytical instruments and laboratory equipment.
• 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:

• Bachelor’s or master’s degree in relevant scientific, engineering, or computer-based area with 3 years' experience in the pharmaceutical industry.
• Experience in authoring and executing analytical instrument and laboratory equipment qualification protocols.
• Knowledge of cGMP regulatory requirements, computerized systems (i.e., 21 CFR part 11) and data integrity.
• Working knowledge of Microsoft Office Applications.
• Must have GMP experience.
• Excellent organization and communication skills.

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.