Nichole Benally

Strategic quality leader, overseeing end-to-end quality operation for peptide research materials, including analytical testing governance, batch control, infrastructure, and regulatory aligned documentation systems. Proven expertise in building, scalable quality frameworks, managing third-party laboratory relationships an implementing structure release protocols to ensure product, integrity, traceability and consistency across expanding product lines. Recognized for developing organized audit ready quality systems that support operational growth while maintaining rigorous testing standard standards.

Lead and manage all laboratory operations ensuring compliance with ISO 17025 and state Quality Assurance standards. Oversee personnel hiring, training, and performance. Maintain and calibrate advanced analytical instruments (HPLC, LC-MS, ICP-MS, GC-MS). Develop, implement, and update SOPs and quality control procedures. Collaborate cross-functionally to optimize lab and sales operations. Ensure timely and accurate testing and reporting for cannabis products, including potency, pesticides, heavy metals, and microbiology. Manage data integrity through LIMS and business tools, investigate quality issues, and enforce corrective actions. Support proficiency testing and maintain regulatory compliance while providing ongoing staff support and managing resources efficiently.

Develop and validate analytical methods using UPLC, LCMS, HPLC, ICP-MS, GC-MS, and HTPLC. Perform routine inspections, electrical troubleshooting, and coordinate instrument maintenance. Lead QA documentation, Out of Specification (OOS) investigations, and root cause analyses. Train and mentor laboratory personnel, update test methods, and manage lab layouts using AutoCAD. Oversee QC testing data review, and reporting in compliance with FDA, ICH, AOAC, and ISO 19001 standards. Manage lab operations including scheduling, budgeting, and safety protocols. Implement Lean Six Sigma improvements to enhance process efficiency and maintain high-quality standards across the Chemistry department.

Independently applied advanced analytical techniques including Atomic Absorption, High Speed Counter Current Chromatography, and Isotope Ratio Mass Spectrometry. Helped developed technologies for isotopically-enriched materials for nuclear power applications.. Led liquid-liquid back extractions and ensured compliance with regulations by developing standards, assessing risks, and training analytical methods. Collaborated with senior management and external national labs (Los Alamos) on research and business objectives.

Independently conducted application, calibration, and integration testing of gas chromatography devices (FROG, VOCAM, VMS, BASS) using Ellvin software. Ensured safe operation and maintenance of lab equipment while testing. Evaluated product against lab standards and adjusted processes as needed. Developed new SOPs and supported new technology implementation. Defined production processes for manufacturing and contributed to departmental reporting and presentations for quality assurance documentation. Collaborated with software engineers, technical engineers for application and product development. Performed data analysis, troubleshooting, and provided customer support. Managed data entry for chemical compounds and adhered to waste handling protocols. Prepared and analyzed sol-gel solutions and coated micro-columns for chromatography.

Led scientific studies including data entry and monthly report preparation using Excel, Powerchart, IRB and REDCap. Drafted and secured grants from local, state, and government sources. Managed IRB submissions and approvals. Oversaw multiple healthcare research projects, implementing study protocols and recruiting participants. Coordinated clinical campaigns to raise funding and awareness in women’s healthcare. Collaborated with clinical staff to manage participant health data and study qualifications. Organized meetings and surveys both in-person and virtually. Conducted informed consent processes and managed participant enrollment. Led regular project meetings and ensured thorough data collection and client communication. Experienced Clinical Trials Manager skilled in leading scientific studies, managing regulatory compliance, and coordinating multi-disciplinary teams. Proficient in data management, patient recruitment, and grant writing, with strong expertise in Good Clinical Practice (GCP) and clinical workflow integration. Adept at mentoring staff and collaborating across clinical and research functions to ensure successful study execution and compliance.

Performed data mining from MRI files for anthropological research related to Missing and Murdered Indigenous Women. Identified controlled substances and quantified blood alcohol levels using GC-MS. Used FORDISC for cranial measurement data. Collected, analyzed and documented trace evidence including hair, fibers, and chemicals. Prepared detailed, accurate reports and maintained evidence records. Supported grant submissions, managed confidential interview data, and monitored project budgets. Provided analytical expertise to law enforcement, ensuring compliance with forensic quality standards. Participated in quality assurance and testified in court as needed.