ELIZABETH A. CONLEY 609-206-4884 (cell) 10 Dakota Trail, Medford, NJ 08055 LIZPSU1@aol.com

PROFESSIONAL PROFILE

Results driven Quality professional with extensive experience in Document Control/Records Management and System/Process Analysis in the Food, Pharmaceutical, Medical Device, and Engineering industries. Proven ability to configure, validate, implement, and manage Documentation/Information Management Systems, including MasterControl. Highly proficient in Microsoft Office software, MasterControl, SharePoint, ComplianceWire, Adobe Acrobat, and SAP.

CORE STRENGTHS

Document Management MasterControl Change Control Computer System Qualification Training Management ComplianceWire Records Management SharePoint ISO 13485 21 CFR Parts 11, 117, 210, 211, 820

PROFESSIONAL EXPERIENCE

4/2014 – present Puratos Corporation, Pennsauken, NJ

As Documentation and Material Master Manager, responsible for management of the Documentation program, including the maintenance and control of all Quality Documents relating to FDA regulations and Safe Quality Food (SQF) standards; change control and review/approval; management and configuration of MasterControl for Puratos US and Canada locations. Also responsible for management of SAP master data, product labeling and technical documentation for 500+ SKUs. Manage team of 5 people.

As System Administrator, responsible for the design, configuration, implementation and maintenance of the MasterControl Document and Training Management modules for all US and Canada locations. Managed the transition from paper-based change control document management system to MasterControl. Preparation and execution of performance qualification test scripts. Preparation/ maintenance of user documentation; provide comprehensive MasterControl training to users at 8 sites.

Team lead for implementation of MasterControl Quality Event forms – Customer Complaint, Non-conformance and CAPA - including form design/testing/approval, preparation and execution of performance qualifications, preparation of user documentation and providing user training.

Develop and support implementation of Safe Quality Foods (SQF) and Food Safety Modernization Act (FSMA) processes, including creating and revising procedures, forms, logs, specifications, etc. relating to SQF/FSMA/GMP activities. Manage periodic review process to ensure applicable documents are reviewed/updated by appropriate departments within required timeframe. Manage training program for 155 employees.

Manage SAP Item Master Data (raw materials, semi and finished goods, packaging and labeling) – item creation, modification and obtaining approvals from various groups through the verification process through MasterControl workflows.

Manage preparation and maintenance of all product labeling and technical documentation; management/ maintenance of all supplier documentation.

Manage customer request process, including documentation requests and completion of customer questionnaires.

Responsible for traceability process and management of traceability team; member of Crisis/Recall team.

Provide support for FDA regulatory inspections, Safe Quality Food audits and customer audits.

11/2009 – 4/2014 Endo Pharmaceuticals, Cranbury, NJ

As Senior Quality Specialist - Documentation, responsible for the management of the Document Control program, including the maintenance and control of all Quality Documents (Commercial and R&D/Clinical); change control and review/approval; management and configuration of the MasterControl Documents and Training modules.

Manage the Document Control program, including transition of a paper-based change control/document management system to MasterControl.

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Responsible for the design, configuration, implementation and maintenance of the MasterControl Document and Training Management modules for the Cranbury business unit. Troubleshoot system issues and interface with MasterControl Tech Support, as necessary.

Execute performance qualification test scripts for initial implementation of MasterControl, and subsequent server relocations, and system upgrade. Prepare/maintain user documentation and provide comprehensive MasterControl training to all site users and company Subsystem Administrators.

Assist in the implementation of MasterControl at other Endo business units for procedural documents and CMO documents; provide consulting services including analysis of current processes, configuration of MasterControl Document Management module, provide user training, perform qualifications.

Team member for implementation of Change Management process in MasterControl, including form design, review and execution of performance qualification, preparation of user documentation and providing user training.

Develop and support implementation of improved business processes, including creating and revising SOPs, forms, logs, specifications, etc. relating to GMP activities. Support QA activities and projects, as needed.

Manage site records management program in accordance with policies and Records Retention schedule.

Manage Investigation/Deviation/CAPA system, including tracking/trending database, reports and applicable metrics.

Provide support for regulatory inspections and filings; provide support for Due Diligence projects. 5/2000 – 5/2009 NexMed (U.S.A.), Inc., East Windsor, NJ

As Senior Manager, Document Control and Information Resources, responsible for the management and maintenance of the Document Control System, including the control, retention, and archival of all GMP/GLP/GCP and corporate documents. SAP implementation team member. Due diligence team member.

Managed and maintained Quality System Document Tracking System, including Document Change Requests, electronic and hard copy revisions of Policies, SOPs, Test Methods, Forms, etc.

Originated and/or revised Quality System Documents, as necessary, for practicality and adherence to GMPs and other regulations; ensure Quality System Documents are clear/concise and meet company standards; provide input/training on good documentation practices.

Developed and maintained databases, as needed, to track/index various types of documentation and data, including Batch Records, Non-Conformances, Training Records, Lab Notebooks, Qualifications, etc.

Implemented and managed disaster recovery process, including scanning of hard copy files and quality control check of electronic images. Managed and maintained Records Management Program for GXP and corporate records, including Records Retention Policy, project closure, indexing of records, off-site storage, retrieval, and destruction.

Integral team member for creation/submission of IND/NDA/eCTD/NDS; implemented and managed process for internal review/approval of regulatory documents ensuring compliance with documentation standards and established formats; reviewed/edited Module documentation; reviewed XML backbone; provided documentation in electronic format, including required bookmarks, hyperlinks, etc.; managed QC effort, including complete verification of hard copy and electronic documents for compliance with appropriate Regulatory Guidelines.

Key documentation resource during audits (FDA PAI, due diligence, etc.); perform internal audits to ensure compliance with regulations.

Team member for SAP implementation; prepared/reviewed system requirements specification, MVP, etc.; prepared qualification test scripts, performed testing, prepared User Guides, provided user training.

2/99 – 5/2000 Ajilon, Media, PA (formerly IMI Systems, Haddonfield, NJ)

As Staff Manager/IT Consultant, managed team of consultants, including interface with individual client managers, performance/salary reviews, project status, and staffing requirements. Member of Y2K Compliance team and Mergers and Acquisitions team.

Performed system analysis and developed qualification test scripts for Y2K testing of mission critical applications; executed test scripts and prepared testing results documentation.

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Performed Quality Assurance review of executed qualification test scripts and supporting documentation.

Implemented a documentation system, including archival requirements for Y2K testing documentation. 12/93 – 2/99 Fresenius Medical Care, Delran, NJ

As Document Control Supervisor, member of compliance team responsible for implementing systems to correct deficiencies addressed in consent decree. Implemented a comprehensive document management/change control system which included standard operating procedures, device history records, master batch records, change documents, and validations for 3 manufacturing facilities.

Managed daily operations, including document review/revision, product release, records retrieval, and user support; developed standards and procedures; conducted system audits.

Designed, developed, and implemented database systems used to control and monitor various functions such as personnel training, calibration schedules, preventive maintenance schedules, product releases, and deviations; developed reports; analyzed data and issued monthly statistical reports to upper management.

Implemented a Records Retention Program

Key documentation resource during audits (FDA, Corporate GMP, etc.) 4/80 – 11/93 Stone & Webster Engineering Corporation, Cherry Hill, NJ

As Documentation/Systems Consultant at PECO Energy, Nuclear Group Headquarters (11/89 – 11/93), integral team member in the development and implementation of an electronic Information Management System which tracked all engineering and design documentation and maintained configuration of 4 nuclear generating units. Participated as Lead Consultant in the implementation of a procedure control system which included several thousand procedures used for the operation of the nuclear units; this system included electronic file cabinets and check-in/check-out mechanisms for electronic revisions and reviews.

Analyzed processes, procedures, work flows, and user requirements. Evaluated existing databases for incorporation into the Information Management System; reviewed and approved data transfer specifications; designed system searches and reports.

Performed in-depth software testing/qualification and data verification; reviewed and approved software enhancements. Controlled system security user profiles; maintained look-up tables; updated Help screens. Developed User Manuals and trained user community in Browse and detailed data entry functions. Conducted system audits. Provided end-user support and troubleshooting; developed system enhancements as work processes changed.

Previous project experience (4/80 – 10/89) includes Document Control/Records Management and Systems Analysis for Nine Mile Point 2 Nuclear Plant and various Fossil and Co-Generation plants; managed Records Retention Center.

EDUCATION

Pennsylvania State University – Bachelor of Arts (General Arts and Sciences)

MasterControl Advanced Analytics (1 day) MasterControl Document Management (5 days) MasterControl Training Management (2 days) MasterControl Quality Events (5 days) Change Control and Configuration Management Preparing Compliant eCTD Submissions (RAPS 2-day workshop) Establishing and Managing Successful Records Management Programs Medical Device Quality Systems: How to Comply with the Regulations Documentation Management and Control in the Pharmaceutical and Related Industries

CERTIFICATIONS

Electronic Records Management Practitioner (AIIM) – lifecycles of records and related concepts Electronic Records Management Specialist (AIIM) – ERM implementation and related processes

PROFESSIONAL ORGANIZATIONS

ARMA International (The Association of Information Management Professionals) Association for Information and Image Management (AIIM)