JOYCE BLADEL, MS, MT (ASCP), CLS, RAC, CQA, CBA 12575 Saint Mark Street, Garden Grove, CA 92845

Cell: (714) 357-6230 * Home: (714) 373-1866 * jb13e0612@westpost.net Performance oriented leader with proven ability to ensure excellence and quality ; recognized for developing high performance teams; successfully built and manag ed departments of Quality Assurance including continuous improvement and impleme ntation of all new regulations, guidelines and standards. Reputation as a direct , honest, and approachable professional with impeccable integrity and ethics. St rong commitment to assist organizations to achieve set goals and standards. KEY ACCOMPLISHMENTS * Implemented World Class Quality Management System (ISO 9001); maintained QMS w ith 'No Observations' for nine years for surveillance and recertification audits by the registrar; received positive inspections and approvals by large pharmace utical companies nationally. * Guarantee QMS demonstrates regulatory compliance (GXP) for performance of Phas e I, II, III, IV clinical trial projects. * Streamlined activities and eliminated waste to significantly decrease the cost of quality and significantly reduce turnaround time for inspections, laboratory testing and release of results. * Generated cost and time savings by managing software validation (IQ,OQ,PQ) and development of standard operating procedures and training for two electronic do cument control systems (MasterControl 2001 and Pilgrim SmartSolve 2009). * Developed process for validation and verification of new assays for R&D includ ing Feasibility Studies, Design Input and Design Ouput, Risk Assessment, Laborat ory Notebook documentation and assay transfer into clinical reference laboratory . * Participated with the Food and Drug Administration to be first reference labor atory to receive Emergency Use Authorization (EUA) approval for H1N1 molecular d iagnostic test. Focus Diagnostics, Inc., Cypress, CA (1992 - 2011) (A subsidiary of Quest Diagnostics,Inc.) Director, Laboratory Quality and Regulatory Affairs for Laboratory and Clinical Trials Pharmaceutical Services (2005 - 2011) * Lead Auditee for an average of 15-20 second party (Pharmaceutical) and third p arty (FDA, ISO, CAP, NYSDOH) audits per year. Directed corrective action proces ses needed to respond to audit summary reports (corrective actions) when applica ble. * Managed corrective and preventive action (CAPA) processes to ensure that corre ct root cause has been identified; guaranteed corrective actions were implemente d and were effective. * Chaired Management Review Board (MRB) for closure of CAPA files and approval/d isqualification of supplier and new material applications. * Provided review of IQ, OQ, PQ protocol and validation reports for instrumentat ion and software installation and development. * Responsible for ensuring that all laboratory equipment was meeting preventive maintenance and calibration schedules and labeled correctly. * Oversaw the Research & Development Department for all design and development p rocesses of new or revised assays to meet compliance requirements. This included Feasibility Studies, Design Input and Design Output, Risk Assessment, documenta tion in laboratory notebooks, assay verification and transfer validation into la boratory production. * Managed the internal auditing system including training and certification of i nternal auditors Developed specifications for the development of an database

for the internal auditors to document, attach supporting documentation and issu e an internal audit report. * Provided oversite for the electronic document control system ensuring that emp loyees had the appropriate roles and responsibilities assigned, correct document approval assignments by management and annual review of documents. * Developed, and managed the external proficiency testing program for the Colleg e of American Pathologists, New York State Department of Health and Internal Ass ay Verification Program. * Ensured new or renewal applications for state and federal licensure requiremen ts were completed and submitted in a timely manner. * Conducted and monitored required internal training programs per applicable reg ulations requirements that included assay training program, competency testing, Good Documentation Practices (GDP), ISO 9001:2008, 21CFR Part 58, Good Laborato ry Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practic es (cGMP) training. * Implemented process improvements to lean out manual processes including develo pment of a database to produce bio-analytical reports for clinical trials client s, implementation of the QC program in the LIS, internal audit database for repo rting and tracking internal audits. * Responsible for the technical and regulatory compliance information contained on the company website. * Agency administrator for Clinical Laboratory Science Continuing Education Accr editing Program for the State of California Department of Health Services and P. A.C.E. Manager, QA/RA, Laboratory Services and Clinical Trials (1992 - 2005) * Project Leader for implementation of ISO 9001:2000 systems in conjuction with the IVD manufacturing division of Focus Diagnostics, Inc. Standardized systems and processes to include ISO13485, ISO 14971, and cGMP requirements for a clinic al reference laboratory. * Developed a robust quality assurance program that met compliance standards by the College of American Pathologists, State of California and New York State Dep artment of Health. * Authored, implemented, and monitored Safety Policies and Procedures for regula tory compliance and served as Safety Officer. * Developed continuing education program approved by California State Department of Health allowing organization to issue continuing education credits to licens ed California Clinical Laboratory Scientists. * Professional Acknowledgement for Continuing Education (P.A.C.E.) Program Admin istrator * Implemented and monitored regulatory guidelines for the Centers of Medicare an d Medicaid Services (CLIA '88) College of American Pathologists, and the New Yor k State Department of Health.

PRIOR EMPLOYMENT 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

AWARDS Compliance Award 2010-Quest Diagnostics, Inc.

Recognition of Excellence-2010 Focus Diagnostics, Inc. MEMBERSHIPS Orange County Regulatory Affairs Association (OCRA) American Society for Quality (ASQ) Regulatory Affairs Professional Society (RAPS) American Society for Clinical Pathology (ASCP) Clinical Laboratory Management Association (CLMA) EDUCATION Master of Science Degree: California State Dominguez Hills, Carson, CA Bachelor of Science Degree: Rio Grande University, Rio Grande, Ohio LICENSES & CERTIFICATIONS State of California Department of Health - License Number: MTA 26336 American Society of Clinical Pathologist - Certification Number: 118929 College of American Pathologists Laboratory Accreditation Program - Accredited I nspector. Regulatory Affairs Certification (RAC) (US) - November 1, 2003 American Society for Quality (ASQ) CQA - June 5, 2004 American Society for Quality (ASQ) CBA - March 3, 2007 Six Sigma Green Belt September, 2009