Location: Raleigh, NC
DIRECT HIRE
Salary: $93-$97/k
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.
Essential Functions & Responsibilities:
· 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
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.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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