QC GC Scientist ChRi Laboratories - 2.5 Saint Paul, MN Job Details Full-time $68,000 - $72,000 a year 22 hours ago Benefits Health savings account Paid time off Parental leave Qualifications Teamwork Empower (software) Chemical extraction Sample preparation ISO standards Drug regulation
FDA 21 CFR
Part 11 GMP Master's degree Bachelor's degree Laboratory standard operating procedures Mass spectrometers (MS) Regulatory/legal compliance standards in production Chemistry Biomedical regulatory compliance Legal compliance Standard operating procedures (SOPs) Technical Proficiency Data analysis software Full Job Description Job Summary We are seeking a highly proficient, instrumentation-focused QC GC Scientist to join our analytical testing laboratory. In this role, your primary responsibility will be to perform routine and non-routine Quality Control (QC) Stability and Release testing using Gas Chromatography systems, supporting our product pipelines across the Pharmaceutical, Medical Cannabis, and Medical Device sectors. A unique and critical requirement for this position is proficiency with both software platforms. You will serve as the laboratory's subject matter expert for the Agilent 7890 GC platform , using Agilent MassHunter for advanced data acquisition and troubleshooting, and Waters Empower for compliant chromatographic data processing, reporting, and sequence management. All workflows must strictly comply with Minnesota Department of Health (MDH) and Office of Cannabis Management (OCM) regulations, cGMP/FDA standards, and
ISO/IEC 17025
guidelines.
Duties and Responsibilities Gas Chromatography Analysis:
Operate, maintain, and perform testing on Agilent 7890 GC systems coupled with various detectors (e.g., FID, MS) for raw materials, finished products, and stability samples.
Dual-Software Data Management:
Use Agilent MassHunter for instrument control and initial data analysis, and seamlessly integrate or process data packages within the Waters Empower environment to ensure standardized reporting.
Cannabis Safety & Potency Testing:
Conduct gas chromatography testing for medical cannabis safety profiles—including residual solvents and terpene profiling—to ensure full compliance with Minnesota regulatory testing protocols .
Routine Stability & Release Testing:
Prioritize high-throughput sample workflows to meet manufacturing release deadlines and time-sensitive pull schedules for stability studies.
Data Review & Integrity:
Conduct rigorous primary and secondary data reviews to ensure that all electronic records comply with ALCOA+ data integrity principles and
FDA 21 CFR
Part 11.
Instrument Maintenance & Troubleshooting:
Perform advanced technical troubleshooting, routine preventive maintenance, and liner/column changes on Agilent 7890 GC systems to maximize uptime.
Investigations & Compliance:
Promptly document and support investigations of Out-of-Specification (OOS) or Out-of-Trend (OOT) laboratory results, ensuring robust root-cause analysis.
Inter-Departmental Collaboration:
Work closely with the QA Coordinator to compile pristine data packages, support equipment qualification (IQ/OQ/PQ), and ensure audit readiness for FDA or state inspections.
Required Skills and Qualifications Education:
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry , or a related scientific discipline.
Experience:
Minimum of 2-5 years of hands-on Gas Chromatography (GC/GC-MS) experience in a high-throughput, regulated laboratory setting.
Instrumentation & Software Expertise:
Proven, hands-on experience operating the Agilent 7890 GC platform, with direct operational proficiency in both Agilent MassHunter and Waters Empower software.
Regulatory Compliance:
Deep structural knowledge of FDA cGMP regulations (21 CFR Parts 210, 211, and 820) , ISO/IEC 17025 standards, and Minnesota medical cannabis testing frameworks .
Sample Preparation:
Advanced proficiency in analytical sample preparation for gas chromatography, including headspace sampling, liquid-liquid extraction, and dilutions. Attention to
Detail:
Uncompromising commitment to strict adherence to written SOPs, analytical methods, and data traceability standards.
Pay:
$68,000.00 - $72,000.00 per year
Benefits:
Health savings account Paid time off Parental leave