QC HPLC Scientist

Job Summary

We are seeking an efficient and highly detail-oriented QC HPLC Scientist to join our analytical testing laboratory. In this role, your primary focus will be performing routine Quality Control (QC) Stability and Release testing to support our commercial and developmental product lines across the Pharmaceutical, Medical Cannabis, and Medical Device sectors.

A critical requirement for this position is proficiency in Waters Empower software (Empower 3) alongside familiarity with Minnesota (MN) regulatory testing protocols for Medical Cannabis. You will provide experience in chromatographic data processing, utilizing Empower to manage sequences, apply processing methods, and generate compliant data packages that adhere to Minnesota Department of Health (MDH) / Office of Cannabis Management (OCM) rules, cGMP/FDA, and ISO/IEC 17025 guidelines.

Duties and Responsibilities

• Routine Release & Stability Testing: Execute routine HPLC/UPLC analysis for raw materials, in-process components, finished product commercial release, and long-term stability studies.
• Cannabis Testing Compliance: Perform cannabinoid potency profiling and ensure safety profile testing complies directly with Minnesota state medical cannabis regulations and testing thresholds.
• Empower Data Processing: Utilize Waters Empower software to build injection sequences, process chromatographic data, integrate peaks, and generate standardized analytical reports.
• Turnaround Management: Prioritize sample workflows to meet strict laboratory turnaround times for manufacturing release schedules and stability time points.
• Data Review & Compliance: Conduct primary and secondary reviews of chromatographic data to ensure compliance with data integrity principles and FDA 21 CFR Part 11 regulations.
• OOS & OOT Investigations: Promptly identify and document Out-of-Specification (OOS) and Out-of-Trend (OOT) results, supporting technical investigations and root-cause analyses.
• Instrument Troubleshooting: Perform routine system suitability checks, preventative maintenance, and minor troubleshooting on Waters HPLC/UPLC systems (e.g., Acquity).
• Compendial Compliance: Strictly follow validated test methods, internal SOPs, and compendial monographs (USP/EP/JP) without unauthorized deviations.
• QA Collaboration: Work alongside the QA Coordinator to compile data packages, archive electronic records, and prepare for external regulatory 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 HPLC/UPLC experience in a high-throughput, regulated QC testing environment.
• Software Expertise: Strong working proficiency in Waters Empower software, including experience managing data channels and processing methods.
• Regulatory Compliance: Understanding of Minnesota medical cannabis laboratory requirements, FDA cGMP regulations (21 CFR Parts 210/211/820), and ISO/IEC 17025 standards.
• Laboratory Proficiency: Proven experience with sample preparation techniques (dilutions, extractions, filtrations) and standard detector types (UV-Vis, PDA, Refractive Index).
• Attention to Detail: Uncompromising commitment to accuracy, documentation precision, and following written step-by-step methodologies.

Pay: $68,000.00 - $72,000.00 per year

Benefits:

• Health savings account
• Paid time off
• Parental leave

Work Location: In person