Quality Assurance Customer Service

Software Development Life Cycle (SDLC) Methodologies • Protocols Development and Execution • Documentation Compliance • Standard Operating Procedures • Internal Audits • Change Control • Validation Project Leader • CAPA • Customer Complaints • LIMS • 21 CFR Part 11 Regulations for Computer Systems Validation • ISO 9001, ISO 13485, ISO 15189 • GLP • GxP • CLIA, CAP and New York General Laboratory Regulations • FMEA • Root Cause Analysis • Laboratory and Personnel Licensure • Pilgrim Software • MasterControl

EXPERIENCE

CLARIENT DIAGNOSTIC SERVICES, INC. (GE HEALTHCARE)

QUALITY ASSURANCE MANAGER, OCT 2009-PRESENT

• Automated document control, Complaints and CAPA process by implementing Pilgrim Software

• Manage all aspects of Document Control, Complaint Handling and CAPA management per regulations

• Provide support and training on processing Change Orders, Root Cause Analysis and CAPA investigation

• Review department SOPs annually per CAP, CLIA and NY requirements

• Facilitate all inspections to stay in compliant with CLIA/CAP, NY and relevant state requirements

• Monitor Pre-analytical, analytical and post-analytical laboratory system indicators including but not limited to: CAPA and complaints resolution, laboratory nonconformance and corrective actions, personnel training competency, completeness of reagent/QC records, completeness of PM records, completeness of test result comparison and accuracy records, including proficiency testing.

• Manage and maintain State, Federal and other certifications and licenses as deemed necessary for the operations of the laboratory

• Run laboratory metrics monthly for the Quality Management Review

• Establish Goals and Objectives for the Quality department

• Supervise 3 direct reports and 3 consultants (computer system validation)

PROJECT MANAGER/SYSTEMS OWNER/ADMINISTRATOR, MAR 2010 - PRESENT

• Develop user requirements, validation plan/protocols and functional specification for computer systems to meet company standard operating procedures, GAMP 5 and 21 CFR Part 11.

• Responsible for project budgets and resource allocation.

• Validated and Implemented Pilgrim Software (SmartDoc, SmartCAPA and SmartTrain)

ENDOLOGIX, INC.

DOCUMENT CONTROL SPECIALIST, JANUARY 2009 - OCTOBER 2009

• Assisted in validation of MasterControl

• Conducted training on MasterControl to all internal employees

• Conferred with document coordinators, engineers and management personnel to resolve discrepancies and ensure required changes are implemented

• Maintained and updated training matrix for 130 employees

• Maintained and control the Device Master Records (DMRs) and Satellite Device Master Record (SDMR)

• Created/revised company standard operating procedures and department procedures

• Prepared and conducted Good Manufacturing Practices audit to evaluate the level of compliance with FDA, ISO and other International Regulatory Requirements

• Performed SDMR audit to ensure accuracy of current document revisions

• Investigated and closed nonconformities assigned to Quality Department (Document Control related)

• Prepared trending reports for Management Review

• Inspected Instruction For Use (IFU) using overlay method (film positives) to ensure accuracy of printing

EDWARDS LIFE SCIENCES THROUGH LAUNCHPAD CAREERS

DOCUMENT CONTROL/LABEL SPECIALIST (TEMP-TO-HIRE), NOVEMBER 2008 - JANUARY 2009

• Responsible for the development of activities related to labeling and documentation, including, but not limited to, initiating Enterprise Change Request (ECR), information audit/verification and problem resolution

• Identified labeling issues, including those raised by team members outside of R&D, such as worldwide operations, marketing, regulatory affairs and clinical affairs. Work with the initiator and/or project leader, team leader and the team to define and implement solutions

CARL ZEISS MICROIMAGING, INC.

QUALITY ASSURANCE SPECIALIST/DOCUMENT CONTROL, MAY 2007 - NOVEMBER 2008

• Managed and maintained Document Control, CAPA and customer Complaints, ensuring compliance with FDA, ISO 13485, ISO 9001 and Canada Medical Device Regulation (CMDR)

• Participated in audits conducted by FDA, CMDR, Japan’s Pharmaceutical Affairs Law (PAL) and ISO Registrar to ISO 9001/ISO 13485

• Prepared and conducted internal audits to evaluate the level of compliance with FDA, ISO and other International Regulatory Requirements.

• Prepared and presented data analysis trending reports and recommendations for management reviews

• Reviewed and revised company standard operating procedures and department work instructions to improve process efficiency and effectiveness

• Conducted training for new hires to the Quality Systems, CAPA and Complaints

• Reviewed and released change orders for completeness and accuracy, and distributed Engineering Change Order (ECO) packages for review

• Performed MRP database updates/maintenance related to ECO activity. Data entry of Bill of Materials (BOM)

CLARIENT, INC.

QUALITY ASSURANCE/DOCUMENT CONTROL SPECIALIST, MAY 2006 - MARCH 2007 (MEDICAL DEVICE OF CLARIENT SOLD TO ZEISS)

• Managed and maintained the complaints and CAPA system, Proficiency Testing, Discrepancy Reports

• Maintained records of staff members and licensure for regulatory purposes

• Facilitated Daily Operations Meeting with all department heads

• Reviewed departments’ Training, Competency, Quality Control and Preventive Maintenance records for completeness

• Facilitated and assisted in regulatory inspection preparation, aided support for external audits from College of American Pathologists (CAP) and New York State

QUEST DIAGNOSTICS

LABORATORY ADMINISTRATOR, PROMOTED TO CUSTOMER SERVICE REP I, MAY 2005 - MAY 2006

• Laboratory Administrator, promoted to Customer Service Rep I

• Managed clinical trials project for the Medical Director

• Developed and maintained database for all incoming samples of clinical trials and specimen return

• Created and revised Standard Operating Procedures for Laboratory Administrators on hematopathology consult and leukemia lymphoma

• Handled incoming client calls to Oncology call center. Contacted clients to request necessary missing information, and test verification

• Performed result entry dictated or written by the pathologists

EMPLOYMENT HISTORY FROM 1996-2004 IN PHILIPPINES (Available upon request)

EDUCATION

University of St. La Salle, Philippines - Bachelor of Science, Major in Computer Science, 1996

SKILLS

Microsoft Office (Word, Excel, Access, PowerPoint, Visio, Outlook, Project)

Software applications: Pilgrim Software, MasterControl, Product Data Management (PDM), J.D. Edwards (JDE), Fourth Shift (ERP System)

TRAINING COURSES

Coaching Conversations for Manager, June 2012

Quality Auditor Certification (ASQ) 2010 – pending certification

MasterControl Documents and Training Module – Salt Lake City, February 2009

Root Cause Analysis/Corrective Action through ASQ, October 2008

Introduction to ISO 2000 through ASQ, October 2008

ISO 13485:2003 Internal Audit Course, through L-Buck Consulting, June 2007

Medical Product Quality Systems, through University of California Irvine Extension, July-September 2007

ORGANIZATIONS

American Society for Quality (ASQ)

Society for Quality Assurance (SQA)

American Clinical Laboratory Association (ACLA)

REFERRALS

Available upon request

SALARY REQUIREMENTS

My salary requirement is in the $85,000-95,000 range.

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