PROFESSIONAL EXPERIENCE

Confidential,Media, Pennsylvania
Project Manager - Sep 2010 to Mar 2011
Acted as Sr. Quality Assurance Auditor for Global QA at leading pharmaceutical company

• Maintained the Global Quality Assurance (GQA) Supplier Management program including the Approved Supplier List (ASL), External Supplier Audit Schedule (MAP), and Quality Technical Agreement (QTA) Schedule.
• Maintained the ASL according to the global supplier management procedure. Received, tracked, and processed requests from global purchasing to add, delete, or modify the suppliers of materials and services on the ASL. Assigned and forwarded the requests to the appropriate team within the External Supply department for evaluation and disposition, and then revised the ASL appropriately.
• Maintained the QTA schedule and Supplier Audit schedule (Master Audit Plan). Sent monthly reminders to auditors of upcoming supplier audits and QTA s to be performed. Received and processed requests to change the schedule as appropriate. Received and filed the completed QTA, Audit Reports, Supplier Responses and Closure Letters.
• Measured and reported the Supplier Management Key Performance Indicators (KPI) including the percent of QTA overdue and the percent of Supplier Audits overdue.
• Prepared and presented the supplier management data to the Global Quality Council at monthly meetings. This included the KPI, identifying the suppliers that had been audited since the previous meeting and highlighting critical and major observations.
• Prepared the supplier management presentation for the Global Product Council monthly meetings. The data for each product included the current external supplier audit, QTA, and regulatory inspections history.
• Performed Internal Audits according to the Master Audit Plan. These included the GQA Corrective and Preventative Action (CAPA) quality system, the GQA Stability Program, and the Canada affiliate marketing, storage and distribution operations.
• Owned the approved change control for a Supplier Management Process Improvement Project. Responsible for the execution of 25 action items including revision of three global supplier management procedures, six associated forms and the qualification of spread sheets used for the Approved Supplier List and Supplier Audit observations.
• Recommended the process improvement to combine the three individual spreadsheets used for tracking the ASL, QTA schedule, and Supplier Audit schedule to eliminate data duplication and mitigate risk of reporting errors.

Confidential,Conshohocken, Pennsylvania
QA Supervisor - Jun 2008 to Jul 2010

• Ensured compliance with global and site procedures in the initiation, execution, documentation and closure of Change Controls, Deviations, Investigations and CAPA related to Engineering, Material Management, and Information Technology. Utilized TrackWise application to initiate and monitor the progress of these records and drive them to closure.
• Provided compliance instruction to Engineering, Material Management, and Information Technology departments for Investigations, CAPA and Change Controls.
• Responsible for approving procedures for Engineering, Supply Chain, and Information Technology (IT), providing subject matter expertise, and ensuring their compliance with global standards, site procedures, and the use of the Document Management System (DMS).
• Maintained site-wide FDA Compliance, including readiness for FDA Inspections and the compliance with global standards and site procedures. Assisted the Director of Quality during two FDA Inspections to defend equipment qualifications, computer system validations, and warehouse temperature mapping and monitoring. Assisted in the preparation and implementation of responses.
• Participated in customer audits, the preparation of related responses and drove the Corrective and Preventative Actions (CAPA) to closure.
• Responsible for the creation and execution of the Internal Audit schedule. Performed internal audits based on ICH 7 Guidelines and cGMP regulations. Approved internal audit reports prepared by QA Inspectors. Initiated associated CAPA records, gain agreement from assignees, and track the records during the resolution process to closure.
• Performed supplier audits; prepared audit reports, and the disposition of suppliers according to global supplier qualification procedures. Tracked the supplier responses to their closure. Audits included contract services for micro testing of environmental monitoring and API, micronization of material, and a global raw material supplier.
• Prepared and presented Quality Management Reviews of the Quality Management System including monthly data collection, calculation and reporting, and quarterly trending and presentation to site management. Responsible to coordinate the quarterly Management Review meetings, preparation and approval of the meeting minutes.
• Supervised two QA Inspectors, whose responsibilities included the inspection of goods receipt, labeling, packaging, shipping, equipment cleaning, housekeeping and Batch Records.
• Resolved issues between QA Inspectors and business partners, and prioritization of assignments.
• Reviewed and approved computer system validation protocols, test scripts, test results and validation reports. Projects included the implementation of barcode scanners for Supply Chain for use with the MRP system, the Distributed Control System (DCS) for Production, Infrastructure qualification for IT, and preparation of site Validation Master Plan.
• Developed validation approach and strategy for computer system enhancements.
• Reviewed and approved manufacturing equipment qualification protocols, test scripts, test results and qualification reports as well as calibration programs. This included reactors, centrifuges, distillation columns, dryers, and related instrumentation as well as their integration with the DCS.
• Responsible to monitor the purified water system, and refrigerated storage in the warehouse.
• Supported the Document Management System remediation project in collaboration with the Global QA sponsor. Facilitated the system compliance assessment. Successfully prepared and presented the project proposal to the management team for approval.

Confidential,Wyomissing, Pennsylvania (formerly Arrow International)
IT Business Relationship Manager, RA/QA - Aug 2006 to Mar 2008

• Ensured compliance with applicable regulations and IT departmental policies and procedures within IT and facilitated their implementation among peer business resources.
• Analyzed business needs for the Regulatory Affairs and Quality Assurance (RA/QA) business areas, defined requirements, and evaluated, prioritized, and implemented technology solutions to meet these requirements.
• Contributed to the preparation of the annual IT Project Portfolio in accordance with the corporate Annual Operational Plan. This includes guidance and support to clients in the preparation of Project Proposals for Executive Committee approval.
• Managed IT projects according to a System Development Life Cycle methodology including definition, planning, organization, validation and project management to assure successful completion on time and within budget.
• Managed and provided technical leadership to two IT Business Analysts in the implementation and support of RA/QA systems. Developed IT resources by facilitating knowledge transfer between them, the business area and third party resources.
• Managed the application support of existing RA/QA computer systems, including fixes, enhancements, upgrades and supplier maintenance. Ensured compliance with the IT Change Control Procedure. Coordinated change control activities between IT Application resources and IT Operation resources.
• Responsible for preparation, approval, and execution of validation deliverables including Validation Plan, Requirements, Design, IQ/OQ/PQ Protocols, and Test Scripts. Coordinated test execution. Led the investigation and resolution of discrepancies. Prepared the Validation Summary Report for approval and facilitated the system release to production.

Confidential,Frazer, Pennsylvania
I T Consultant, Corporate IS Compliance - Apr 2002 to Aug 2006

• Received Project Management Certification for participation in a week long Project Management Boot camp.
• Project Manager for the development and approval of a global IS Computer Validation System Life Cycle Policy and seven procedures according to the IS Document Management Process. Responsible for writing the policy, developing training materials, and training corporate IS personnel.
• Project Manager for the integration of Change Management and Change Control procedures, processes and tools across organizational units. Responsible for writing the global Change Control and Change Management procedures.
• Project Manager for the implementation of a file tracking system for validation and related documents. Responsible for validation deliverables, collaboration with the vendor and IT support for the design and installation of database. Provide ongoing support of the system.
• Validation consultant for a global Document Control System upgrade. Responsible for validation deliverables including Validation Plan, Requirements, IQ/OQ/PQ and Summary Report. Communicated the regulatory requirements to the vendor.
• Managed 15 validation contractors for the global Laboratory Automation Compliance Enhancement and Standardization (LACES) Program. Responsible for hiring, on-boarding, training, reconciling invoices, managing supplier relations, demand/capacity planning and on-going contractor supervision. Additionally, developed the validation test plans for LACES enterprise computer systems Laboratory Information Management System (LIMS), Chromatography Data Acquisition System (CDAS) and Data Archive (DA).

Confidential,Wayne, Pennsylvania
Master III Validation Specialist - Jun 1999 to Apr 2002

• Managed and executed the system validation of pharmaceutical laboratory systems in a cGLP environment.
• Developed Validation Plans, Validation Protocols, Requirements Specifications, IQ, OQ, PQ (UAT), and Validation Reports. Performed 21 CFR Part 11 assessments on laboratory instruments.
• Executed IQ, OQ, PQ tests and resolved exceptions (software errors) encountered during protocol execution.
• Led client validation project team meetings with representatives from the Users, IT, QA, Regulatory, and Validation Departments.

Confidential,Sellersville, PA
Supervisor Laboratory Services - Jun 1992 to Jun 1999

• As Supervisor Laboratory Services coordinated the integration of Quality Control S.O.P. Manuals following the merger of the company, responsible for maintenance of the S.O.P. Manuals for QC Department.
• Coordinated the QC Department validation of computerized equipment and compliance with corporate procedures and government regulations.
• As Supervisor Laboratory Automation appointed to the Computer Validation Committee with the Director of MIS and Director of QA, responsible for preparation of the Corporate Validation Policy.
• Presented the TEVA USA Computer Validation Policy at a corporate conference on Validation, held at corporate headquarters in Israel.
• Project Leader for the acquisition, implementation and validation of a chromatography data system for QC Department.
• As LIMS Project Leader coordinated multiple departments, project management and validation consultants and LIMS vendors following a System Development Life Cycle.
• As Finished Product Group Leader supervised Chemists and Technicians in the analysis of finished product samples in the QC Analytical Lab. Responsible for investigation of out of specification (OOS) results.
• As Chemist responsible for the analysis of finished product and stability samples including assay, content uniformity, dissolution, identification and degradant/impurities.

Confidential,Mainland, PA
Microbiology Supervisor - Jan 1986 to Jun 1992

• As Microbiology Supervisor managed and maintained Microbiology Laboratory, coordinated lab personnel and prioritized assignments. Responsible for Microbial Limits testing and investigation of out of specification (OOS) results.
• As Microbiologist responsible for USP Microbial Limits testing as well as customer method testing of cosmetics, foods, pharmaceuticals, and raw materials.
• As QC Inspection Supervisor responsible for Packaging Line inspections, supervised four QC Inspectors.

EDUCATION
Bachelor of Arts, Biology