AREAS OF EXPERIENCE
Quality Management, Quality Assurance, Quality Planning, Continuous Improvement (Lean, Six Sigma, 5S), Project Management, Team Building & Collaboration, Laboratory Processes, Biopharmaceuticals, Internal/External Audits, Incident Management, Root Cause / CAPA, GXP & Quality Trainer, Managing Crisis Situations, Acquisition/Integration, Process and System Design, Change Management, Clinical Trials, Strategic Planning, Customer Relations, Regulatory Knowledge (ICH, GMP, GCP, GLP, FDA, CLIA, EU, PPTA, HIPAA, CAP, ISO, CLSI)
" Spearheaded departmental global restructure
" Improved employee engagement scores in all categories during first year in role
" Directed Quality Systems integration workstream during acquisition
" Hosted CLIA and FDA inspections resulting in no observations
" QA Site Head for four locations
" Line Manager for local QA staff as well as global team, including planning, assigning, & directing work; appraising performance, guiding professional development; rewarding and disciplining employees.
" QA subject matter expert for assigned projects
" Consultant to key development groups for assessment of compliance with regulations, guidelines, corporate standards and policies.
" Oversee audit and inspection activities, including coordination of internal customer-initiated audits, regulatory inspections and vendor audits.
" Author QA Policies and Procedures.
" Serve as Global QA Contact for assigned customers and functional areas.
" Monitor documentation, reporting, and closure of compliance issues and CAPAs.
" Support proposal and quality plan reviews.
" Conduct trend analysis and report QA metrics.
" Develop QA budget and staffing requirements.
Director, Quality Systems
" Led organization to achieve initial CLIA certification
" Developed and Implemented Initial Quality Program, Policies and Procedures
" Oversaw and managed all Quality Systems to include the Safety Program
" Primary Quality and Compliance expert for CLIA, GCP, GLP, ICH, and HIPAA compliance for projects
" Ensured site compliance was maintained for all operations
" Executed internal compliance and quality audits and hosted inspections as required by regulatory agencies, suppliers, and third parties
" Performed external compliance and quality audits on subcontracted entities and vendors
" Developed, implemented, monitored, maintained and provided education and training on quality policies and procedures and employee handbook content to encourage compliance with laboratory testing regulations and best practices
" Promoted high quality services and a safe, enjoyable work environment
" Identified operations subject to Federal, State and local rules and regulations and maintained knowledge of applicable regulatory requirements to provide strategic initiatives
" Advocated for continuous improvement initiatives and benchmarking opportunities
" Actively participated in national forums regarding regulatory processes
" Prepare and submit QA staffing requests
" Prepare and monitor QA budget
Sr. Quality Assurance Associate
" Led implementation of Trackwise System and vendor management program
" Oversaw Compliance and Audits and Documentation Management Departments to ensure compliance with regulatory and industry standards.
" Managed the following quality systems:
Internal/External Audits, Discrepancy and CAPA Management, Change Control and Documentation, Customer Complaints, Supplier Evaluation and Approval, Equipment/Instrument Services, Reagent Quality Control Testing
" Hired and trained new employees and conducted performance reviews
" Created and conducted site trainings on quality systems
" Tracked, trended, and presented quality metrics and Key Performance Indicators
" Utilized project management and leadership skills to achieve implementation of new systems, process improvements or other changes
" Responsible for final review and evaluation of test documentation
Cytogenetics Technologist II
" Nominated as Laboratorian of the Year
" Responsible for following all SOPs related to bone marrow and solid tumor specimen/reagent preparation and analysis, microscopy, karyotyping, quality control, and final reporting of results to clients. Assisted with training of new employees and the revision of SOPs
California State University, Dominguez Hills, CA
MS Quality Assurance, Manufacturing - 2008
North Carolina State University, Raleigh, NC
BS Biochemistry, Minor in Genetics 1999
American Society for Quality Certified Quality Auditor, 2005
American Society for Quality Certified Quality Manager/Organizational Excellence, 2008
American Society for Quality Certified Quality Improvement Associate, 2011
Expert GCP Accreditation 2013, 2014
American Society for Quality (ASQ) since 2004,
Section Chair 2013-14
Voice of the Customer Chair 2012-2013
Newsletter Chair 2011-12
REFERENCES AVAILABLE UPON REQUEST