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SUMMARY OF THE POSITION:

We are seeking a highly skilled QC Instrument Metrologist to join our Quality Control team. This role is responsible for the qualification, calibration, maintenance, and lifecycle management of analytical instruments in a GMP-regulated laboratory environment. The ideal candidate will ensure instrumentation compliance with regulatory standards, minimize equipment downtime, and uphold data integrity across QC operations. This is an on-site position at our Raleigh, NC site.

EDUCATION, EXPERIENCE, AND/OR SKILL:

• Bachelor’s degree in chemistry, Biochemistry, Engineering, or a related scientific field.
• Minimum 5 years of laboratory experience, including 2+ years in instrumentation roles.
• Strong knowledge of laboratory instruments (e.g., HPLC, FTIR, UV-Vis, TOC, Karl Fischer, Isolator, KTA).
• Familiarity with GMP, 21 CFR Part 11, USP <1058>, and data integrity principles.
• Experience with instrument qualification protocols (IQ/OQ/PQ) and validation.
• Proficiency in quality systems including deviations, CAPAs, and change controls.
• Excellent organizational, communication, and problem-solving skills.

• Supervise day-to-day activities related to QC Instruments, including Scheduling calibrations, PM’s and troubleshooting tasks.
• Ensure all QC Instruments are qualified, calibrated and maintained in accordance with SOPs and GMP requirements
• Lead and support Instrument qualifications (IQ/OQ/PQ) requalification and decommissioning
• Serve as a liaison with vendors, repairs and qualifications support
• Manage and maintain instrument documentation such as calibration records, usage logs and deviation reports
• Lead or support investigations related to equipment failures, data integrity or OOS results to instrument performance.
• Support change controls, deviations, CAPA’s and other quality systems documentation relevant to Instrumentation
• Train and mentor QC analysts in proper Instrument use troubleshooting and care
• Participate in audits and regulatory inspections; provide instrument-related information and documentation as needed
• Collaborating with IT and validation group on computerized system validation and data integrity compliance
• Identify and implement continuous improvement opportunities related to Instrumentation or workflow