Brittany Mincher

About

With a Master's degree in Health Care Administration from the University of Phoenix and a Bachelor's in Human Biology from North Carolina State University, I have cultivated a robust career in project and operations management within the pharmaceutical and clinical laboratory sectors. Currently, as a Project Manager at PAI Pharma, I lead the calibration of pharmaceutical assets, optimizing processes and enhancing compliance. My previous roles include Operations Manager at SCITECK Clinical Laboratories, where I improved COVID-19 testing capacity and accuracy, and Project Lead at ImmunoTek Bio Centers, where I implemented quality improvement strategies. I have also contributed to quality assurance at Genova Diagnostics and Enplas Life Tech, focusing on process efficiency and accuracy. My expertise lies in project management, quality assurance, and operational efficiency, consistently delivering results that enhance productivity and compliance.

Experience

• Project Manager, Pharmaceutical Validation and Calibration · PAI Pharma08-01-2022

  Led the precise calibration of 3,200 pharmaceutical manufacturing assets by coordinating cross-functional teams and collaborating with both internal departments and external vendors. Enhanced operational efficiency and ensured compliance with industry standards. Managed 120 calibration schedules across multiple facilities, delivering projects within budget and improving productivity. Designed and implemented project management frameworks specifically for validation processes, yielding significant productivity gains. Optimized resource allocation and introduced parallel processing workflows, decreasing calibration cycle times by 30%. Improved on-time task completion rates from 75% to 92% using scheduling and tracking methods in SAP and Blue Mountain RAM. Refined validation protocols, elevating first-pass success rates for calibration from 79% to 95%. Developed robust risk management protocols, resulting in a 35% reduction in out-of-tolerance incidents and a 45% decrease in calibration-related manufacturing delays. Enhanced vendor management system, reducing delayed external calibrations by 50%. Focused on quality control practices, leading to zero major findings in recent regulatory audits.

• Operations Manager, Laboratory (Contract) · SCITECK CLINICAL LABORATORIES INC02-01-2022 – 08-01-2022

  Directed clinical, diagnostic, and forensic laboratory projects from inception to delivery during the COVID-19 pandemic, effectively managing an annual operational budget of $200K to meet strict timelines and quality standards. Optimized budget allocation for lab equipment, testing supplies, and staffing, ensuring resources were aligned with project objectives. Fostered a high-performance environment by mentoring a team of three laboratory technicians, enhancing team skill sets and project outcomes. Developed a Quality Management System (QMS) adhering to ICH, GCP, and FDA regulations. Revamped standard operating procedures (SOPs) into actionable, user-friendly tools, improving daily efficiency and maintaining forensic standards. Implemented strategic process improvements, increasing COVID-19 testing capacity by 30%, eliminating the need for additional staff. Led quality assurance initiatives that raised accuracy rates to 99.5% and streamlined processing times. Reduced project completion times by 20% and improved cross-functional collaboration efficiency by 35%. Introduced a cross-training program that empowered team members and decreased turnaround times by 25%.

• Project Lead, Quality Assurance · ImmunoTek Bio Centers, LLC12-01-2020 – 02-01-2022

  Improved operational efficiency and performance across multiple departments by formulating and implementing quality improvement strategies utilizing PowerBI. Replaced manual data entry with a barcode scanning system, resulting in a 90% reduction in labeling errors. Redesigned the floor layout and workflow for donor processing, achieving a 35% decrease in wait times. Increased workflow efficiency by 40% and maintained a 95% compliance rate with standard operating procedures (SOPs) through thorough documentation and in-depth audits. Identified and resolved root causes, leading to a 20% reduction in recurring issues and a 15% improvement in overall process efficiency. Refined documentation by implementing electronic forms, leading to a 40% decrease in documentation errors. Built a comprehensive training program to address FDA compliance gaps, resulting in zero major findings during inspections and internal audits. Instituted automated alert systems for temperature monitoring deviations in plasma storage, reducing out-of-range incidents by 75%. Developed a color-coded system for plasma test vials, increasing sample acceptance by 40% and minimizing shipment errors. Implemented a preventive maintenance schedule that boosted equipment uptime by 50%. Through root cause analysis training, empowered staff to independently resolve 60% of quality issues within 12 months.

• Laboratory Support Specialist · Genova Diagnostics07-01-2020 – 09-01-2020

  Trained in microbiology and colorimetry laboratory departments, working closely with cross-functional teams to deliver critical analytical support during high-demand periods and enhance quality processes. Performed quality reviews of over 600 diagnostic test samples using multiple testing methodologies, ensuring reliable and accurate assessments. Meticulously documented the chain of custody for sensitive materials to maintain data integrity throughout the handling process. Reduced new employee onboarding time by 25% by creating a comprehensive training protocol that did not compromise accuracy standards. Conducted root cause analysis, initiated Corrective and Preventive Actions (CAPAs), and contributed to the development of Standard Operating Procedures (SOPs) to address laboratory issues and continuously improve testing accuracy.

• Quality Assurance Technician · Enplas Life Tech, Inc.03-01-2020 – 07-01-2020

  Rectified a persistent manufacturing flaw in collaboration with the engineering team, resulting in a 15% increase in product yield. Contributed to quality audits, ensuring there were no significant findings by organizing records of all inspections and deviations. Conducted inspections of over 500 medical-grade plastic components daily, achieving a 99.8% accuracy rate. Streamlined the inspection process by implementing an efficient checklist system and maintaining shelving systems for optimal item access, enhancing quality review efficiency by 20%.

Education

• University of PhoenixMaster's degree, Health/Health Care Administration/Management
• North Carolina State UniversityBachelor of Science - BS, Human Biology

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