Laboratory Manager Production Supervisor
Resume:
Paul Matsui
Northridge, CA 310-***-**** ***********@*****.***
Analytical, precise, and passionate Senior Manager of Quality Assurance with 30+ years of diverse laboratory, production, and project management experience. Collaborative and adaptable leader skilled in professionally communicating, improving processes with innovative solutions, and managing compliance, documentation, project deadlines, and accreditations in fast-paced and dynamic environments.
Professional Experience
PerkinElmer CDPH Branch Laboratory Valencia, CA
Senior Manager of Quality Assurance October 2021 – June 2022
●One of 4-member on-site leadership team
●Direct quality assurance initiatives for a $25M, 134K square foot BSL-2, public health clinical laboratory with 24/7 operations by strategically planning, contributing to the testing of up to 100K specimens per day
●Improve operations by collaborating with executive leaders and researching best practices, impacting the work of 450+ employees
●Develop and mentor a strong QA team
●Perform Quality Audits
●Perform gap analysis
●Secure and maintain CAP accreditation and CLIA certification by analyzing requirements and conducting quality audits, ensuring optimal compliance at all times
●Coordinate employee training, continuing education, and testing by leading performance reviews and leveraging excellent organizational skills, exceeding deadline expectations
●Coordinate and document equipment IQ/OQ/PQ
●Investigate and document QER, NC, root cause, and CAPA
●Develop and modify standard operating procedures by monitoring operational trends and reviewing audit results, boosting compliance scores while increasing turnaround times
●Organize laboratory documentation using careful attention to detail, reducing errors and discrepancies
●Submitted 2 FDA EUA Submissions
●Decontaminate and decommission lab
Psychemedics Corporation Culver City, CA
Quality Assurance Director February 1999 - October 2021
●Steered quality assurance programs by cooperating with leaders to implement continuous improvements, resulting in more streamlined operations for 100+ employees in a clinical and forensic toxicology lab
●Developed and mentored a strong QA team
●Perform Quality Audits
●Perform gap analysis
●Investigate and document NC, root cause, and CAPA
●Maintained CAP, CLIA, NYSDOH, SCC, and ISO accreditations, licenses, permits, and certifications by controlling documentation and resolving discrepancies, confirming adherence with all requirements
●Spearheaded inspections, audits, and blind quality control programs by observing trends and processes, consistently determining areas for growth and improvement
●Trained employees by assessing performance, communicating changing rules and regulations, and demonstrating standard procedures, reducing non-compliance
●Supported method development by conducting thorough research and incorporating best practices, growing efficiency while prioritizing quality
Psychemedics Corporation Culver City, CA
Extraction Laboratory Manager February 1993 - April 2016
●Managed 20 employees by coordinating hiring, training, scheduling, and performance management,
●Led laboratory activities by preparing standards and controls, consistently surpassing productivity and quality goals
●Responsible for operation and maintenance of the lab
●Analysis of specimens by Mass Spectrometry
●Mass spectrometry method development
●Ordered supplies by performing physical counts and anticipating needs, improving order accuracy and standing orders
Additional Experience
Psychemedics Corporation Extraction Chemist - 7-91 to 2-93
Diagnostics Products Corporation Production Supervisor - 6-89 to 5-89
Banner Gelatin Products QC Chemist 8-86 to 7-87
ISO/IEC 17025:2017 Internal Auditor
College of American Pathologists Auditor
Core Competencies
Quality Assurance, Quality Control, Interpersonal Communication, Forensic and Clinical Laboratory Operations, Manufacturing Operations. Documentation, Problem-Solving, Method Development, Bench Chemistry, Mass Spectrometry, Decision-Making, Process Improvement, Compliance, Auditing, Corrective Actions, Leadership
Technical Skills
Microsoft Office (Word, Excel, Outlook, PowerPoint), MediaLab, Qualtrax, ChemDraw, ChemStation, MassHunter
Education
Bachelor of Science in Chemistry, Biology Minor, California State University – Chico
Publications
Schaffer, M., Cheng, C., Chao, O., Hill, V., & Matsui, P. Analysis of cocaine and metabolites in hair: validation and application of measurement of hydroxycocaine metabolites as evidence of cocaine ingestion. Anal Bioanal Chem, 2016 Mar; 408(8):2043-54
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