Results-driven manufacturing professional with extensive experience in biotech operations, cGMP compliance, and people leadership. Proven ability to oversee teams of 10+ employees, drive process improvements, manage operational escalations, and partner with Quality Assurance on deviation investigations and technical writing. Adept at training and developing personnel, optimizing production workflows, and ensuring regulatory compliance while consistently meeting business and production objectives.
Expanded operational expertise through qualification in Harvest and Media operations within ISO 5 and ISO 7 manufacturing environments, increasing flexibility to support multiple production areas and business needs. Collaborated with Quality Assurance to streamline record review activities, support RFI closure, improve record completion timelines, and enhance compliance outcomes. Supported onboarding and development of new associates through mentoring and knowledge sharing while promoting GMP compliance, operational excellence, and continuous improvement initiatives.
Served as interim manager for teams of 10+ employees, leading escalations and process troubleshooting, managing production scheduling and equipment calibration activities, overseeing cGMP documentation revisions, and mentoring associates into SME and trainer roles while driving process improvements to enhance operational efficiency, compliance, and production performance.
Provided interim leadership for manufacturing teams of 10+ employees, enhancing operational efficiency through training development, production schedule management, cross-functional collaboration with Quality Assurance on deviation investigations and technical writing, process troubleshooting, and GMP documentation review to ensure regulatory compliance and inspection readiness.
Established as a Subject Matter Expert (SME) while supporting GMP-regulated manufacturing operations and adhering to safety standards. Transitioned from Logistics to Selection operations, developing expertise in Oracle, MES, and BMRAM systems while training team members on operational procedures, system utilization, and manufacturing floor activities.
Demonstrated strong leadership and operational excellence by managing a fast-paced salon environment, training and mentoring team members, and ensuring compliance with OSHA regulations, Oregon state laws, and facility safety policies to maintain a safe, efficient, and high-performing workplace.