James L Mosley

Biography

Currently, Jim is the Program Analyst for the Eastern Energy Resource Science Center (EERSC) and Eastern Mineral & Environmental Resource Science Center (EMERSC).  His primary role as a Program Analyst is to implement and maintain resource use and administrative support to the EERSC and the EMERSC. His responsibilities include providing routine budgetary and financial advice to project personnel regarding processes, procedures, regulations, and requirements for agreements and reimbursable sales orders for Technology Transfer compliance for collaborative program research.  Jim also provides guidance to project personnel regarding process, procedures, policy, regulations, and requirements for human resources support as well as Financial Operating Procedures (FOP).

In addition, Jim performs quality assurance and quality control activities, that include collaboration with Science Center Director, Associate Science Center Directors, and project personnel to initiate and implement Laboratory Quality Management System (QMS) requirements. He served on the audit team, acting as the lead auditor for several audits, during the three-week QMS ready review performed for the Central Energy Resources Science Center. Jim serves as a liaison with the Bureau QMS working group for QMS-related Bureau-wide policy development and implementation matters among laboratory personnel, Laboratory Managers, the QMS Manager, and Science Center Management. Specifically, Jim is the chair for the Bureau-wide subgroup developing specific guidance for publishing laboratory methods under the Bureau QMS. Jim also is using his experience with quality management systems, quality assurance, and quality controls to develop training modules as a member of the Bureau-wide training subgroup. Finally, Jim is currently a member of the QMS team reviewing laboratory SOPs to ensure quality controls are included as described in the Energy and Minerals Mission Area Quality Assurance Requirements.

Jim comes to US Geological Survey with over 20+ years of quality management program and project management experience from the private sector (medical, pharmaceutical and commercial manufacturing entities), 4 years Federal service, and 6 years (domestic and foreign billets) in the U.S. Army. His work experience includes supervisory clinical and manufacturing laboratory QMS and production manufacturing. In addition, Jim lead and provided training for internal, and external auditing that included corrective and preventive action (CAPA) plans based on root cause analysis (RCA) using 5Why and Fishbone tools for many International Organization for Standardization (ISO) standards including: ISO 17025, ISO 9001:2008, ISO 14001:2004, and Clinical Laboratory Improvement Amendments (CLIA) laws and regulations. He is an expert in clinical and regulatory compliance standards, budgeting and finance, laboratory diagnostics and reporting, data management, and statistical analyses for scientific research and development processes.  His specialized training includes human resources, financial management, qualitative and quantitative analytical techniques for quality assurance and quality control, risk management processes and analysis database development for managing program and workflow efficiencies.  

Service Award

  • USGS Group Honor Award for Excellence in Service, 05/18/2018

Education

  • Master of Business Administration (MBA) Degree - University of Maryland University College – Adelphia, MD.
  • Master of Science (M.Sc.) Degree in Biotechnology and Regulatory Affairs - University of Maryland University College – Adelphia, MD., Graduated with Honors. 
  • Bachelor’s degrees in Microbiology & Biotechnology University of South Florida, Tampa Fl. and University of Maryland University College – Adelphia, MD.
  • Associates of Arts degree from Hillsborough Community College in Tampa, Fl.

Professional Work Experience

  • 2014 to Present – U.S. Geological Survey Program Analyst, Eastern Energy Resource Science Center (EERSC) and Eastern Mineral & Environmental Resource Science Center (EMERSC) with previous experience from the Office of Policy and Analysis (OPA), Reston, VA
  • 06/2010 to 07/2013, Supervisor, Dietz & Watson, Inc. – Baltimore, MD. for Production and Laboratory QA/QC Services. Responsibilities included QMS program development, inspection, laboratory chemistry and microbial testing protocols, and overseeing the manufacturing for machine processing, cooking, and sanitizing testing for machinery according to Hazard Analysis of Critical Control Points (HACCP), Sanitizing Standard Operating Procedures (SSOP), Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP), and Good Manufacturing Procedures (GMPs) on a daily bases for trend analysis with upper management for records management and USDA reporting that maintained department compliance for food safety regulatory inspections. QMS responsibilities included authoring and reviewing SOPs, lead and training for internal, and external auditing including CAPA plans based on RCA using 5Why and Fishbone tools for many ISO standards including: ISO 17025, ISO 9001:2008, ISO 14001:2004.
  • 06/2003 to 06/2010, Supervisor, Smithfield, Inc. - Landover, MD. for Production and QA/QC Laboratory Services. Responsibilities included QMS program development, inspection, laboratory chemistry and microbial testing protocols, and overseeing the manufacturing for machine processing, cooking, and sanitizing testing for machinery according to HACCP, SOPs, SSOPs, GLP, and GMP on a daily basis for trend analysis with upper management for records management and USDA reporting that maintained department compliance food safety regulatory inspections. QMS responsibilities included authoring and reviewing SOPs, lead and training for internal, and external auditing including CAPA plans based on RCA using 5Why and Fishbone tools for many ISO standards including: ISO 17025, ISO 9001:2008, ISO 14001:2004.
  • 06/2000 to 06/2003, Supervisor, Tmesys/Pharmerica for Pharmacy Services Center - Tampa, FL. Responsibilities included working with human resources (HR) and upper management for the supervision, recruitment, development and retention of approximately 25 associates for providing pharmaceutical prescription pharmacy services to customers, including interviewing, hiring, training, coaching and feedback sessions for assigned employees.
  • 06/1991 to 06/2000, Clinical Trials Coordinator, Tampa General Hospital/University of South Florida Medical School Pharmaceutical Research Clinic – Tampa, FL. Supervised associates for the order and processing of daily pharmaceutical needs for internal and external medical clinic research customers.  Provided medication preparation and compounding, including intravenous (IV) and oncology pharmaceuticals, topical compounds and pediatric dosing. Researched with medical teams for the development for drug utilization's criteria (DUE'S) for cost analysis verses benefit of use with upper management.  Collaborated with clinical medical teams to implement and manage pharmaceutical and medical device research protocols, data collection procedures, implement informed consents, monitoring strategy decisions, and gathered data on new pharmaceuticals sponsored by manufacturers as required by the FDA, GLP, CLIA & OSHA.
  • 06/1983 to 06/1990, Technical Writer, United States Army, 62 Bravo –Heavy Equipment Repair Manual Technical Writer for New Equipment: Tour of duties included billets in Tacoma, Washington State (Fort Lewis, now Joint Base Lewis-McCord) and Southern Germany.

Affiliations

  • 2015 – Present, Member, Association of University Technology Managers (ATUM)
  • 2010 – Present, Officer and member with Annandale Toastmasters Club, Toastmasters International