Accomplished Management Executive with extensive clinical laboratory QA/QC background eager to contribute talents toward supporting a dynamic organization in achieving quality and compliance goals.
Specialization in pharmaceutical industry with proficiency in operations leadership, project/program management, quality control and assurance (QC and QA), compliance audits, document control, and corrective and preventive action (CAPA). Advanced experience in Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Documentation Practices (GDP), cGMP (current Good Manufacturing Practices) and laboratory safety rules and regulations. Well-developed analytical, troubleshooting, documentation, reporting, leadership and organizational skills. Adept at authoring and implementing compliance policies and procedures and quality systems.
Winner of 2010 Compliance Award from Quest Diagnostics and Recognition of Excellence in 2010 from Focus Diagnostics for exhibiting exceptional performance.
Championed multiple process improvements within Laboratory Quality & Regulatory Affairs department including development of a database to generate bio-analytical reports for clinical trials clients.
Resourcefully implemented quality control program in Laboratory Information System.
Devised database to streamline and automate internal audit reporting and tracking functions.
Measurably enhanced department efficiency through implementation of an electronic unit code request approval database.
Partnered with FDA to be the first reference laboratory to receive Emergency Use Authorization (EUA) approval for H1N1 molecular diagnostic test in 2009.
Project-managed Clinical Reference Laboratory and Clinical Trials Divisions Initial ISO Certification 9001:2000.
Focus Diagnostics, Inc. (subsidiary of Quest Diagnostics, Inc.), Cypress, CA, 2005 to Present
Director, Laboratory Quality & Regulatory Affairs (2005 to Present)
Spearhead compliance efforts for Laboratory and Clinical Trials Pharmaceutical Services with full accountability for maintaining ISO 9001:2008 requirements and implementation of new regulations, guidelines, and standards.
Oversee electronic document control and ensure alignment with GCP, GLP, and cGMP for performance of Phase I, II, III, IV clinical trial projects conducted by Laboratory Services and the Clinical Trials divisions.
Direct and participate in approximately 30 second- and third-party audits for Laboratory Services and Pharmaceutical Clinical Trials annually.
Steer CAPA process and serve as Chairperson of Laboratory Management Review Board..
Review and authorize IQ/OQ/PQ (Installation Qualification/Operational Qualification,/Performance Qualification) protocols and validation reports for instrumentation and software.
Professional Experience continued, Page 2 of 2 Yyyyyy x. yyyyyy
Demonstrate exceptional leadership capabilities in administering calibration and preventive maintenance program, managing Internal Audit program, and supervising efforts of R&D Department.
Navigate development and execution of Internal Assay Verification Program for laboratory services.
Diligently administer internal training programs for assay documentation, competency testing, job authorization grids, GDP, ISO 9001:2008 and 21CFR Part 58, and GLP.
Prepared and cost-effectively administered annual budget for Quality Systems Department.
Serve as agency administrator for Clinical Laboratory Science Continuing Education Accrediting Program for State of California Department of Health Services and P.A.C.E. (Professional Acknowledgement for Continuing Education).
Actively serve as member of College of American Pathologists (CAP) Laboratory Accreditation Program as an accredited inspector.
Manager, QA/RA, Laboratory Services and Clinical Trials (1992 to 2005)
Integral member of Focus Quality System team for development and implementation of ISO 9001:0000 xxxxxx xxxx , xxxx , xxxxx 00000:2003 certifications, FDA inspections and continuing education.
Exhibited outstanding versatility as ISO 9001:2000 Certified Internal Auditor, P.A.C.E. Program Administrator, and accredited inspector for CAP Laboratory Accreditation Program.
Developed and administered robust quality assurance program in adherence to stringent requirements of College of American Pathologists, State of California and New York State Department of Health.
Authored, implemented, and enforced safety policies and procedures as company safety officer.
Assembled continuing education program approved by California State Department of Health enabling Focus Diagnostics, Inc. to issue CE credit to licensed California Clinical Laboratory Scientists.
CLIA Expert Surveyor, Health Care Financing Administration (CMS)
Manager of Satellite Stations; Laboratory Manager, BioDiagnostics Laboratories, Torrance, CA
Supervisor, Chemistry Department; QA Manager, San Pedro Peninsula Hospital, San Pedro, CA
M.S. Degree, California State Dominguez Hills, Carson, CA
B.S. Degree, Rio Grande University, Rio Grande, Ohio
Six Sigma Green Belt, 2009
CBA (Certified Biomedical Auditor) C American Society for Quality, 2007
CQA (Certified Quality Auditor) C American Society for Quality, 2004
RAC (Regulatory Affairs Certification), 2003
MTA, State of California Department of Health C License #26336
American Society of Clinical Pathologists, Certification # 118929
Orange County Regulatory Affairs Association (OCRA) American Society for Quality (ASQ)
Regulatory Affairs Professional Society (RAPS) American Society for Clinical Pathology (ASCP)
Hiring Agent Name
I am currently seeking a challenging career opportunity as a <INSERT JOB TITLE/POSITION> and am submitting my resume for your review. In advance, thank you for your time and consideration.
In addition to excellent academic and professional credentials, I bring to you solid experience in directing regulatory compliance for clinical laboratory operations, outstanding expertise in quality management system development and management, and an exemplary blend of talents in managing audits, clinical trial projects, QA/QC policy and procedure development, and calibration and preventative maintenance programs. To complement these qualifications, I offer polished analytical, technical, documentation and communication skills.
As a proactive contributor to your organization, you will find me to be a self-motivated professional and stellar leader committed to supporting you in achieving your objectives through integrity and dedication. I am confident that I could be a valuable asset to your company, and look forward to interviewing with you in the near future.
Yyyyyy x. yyyyyy
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