SUMMARY:

• Validation, IT, QA, Documentation Management
• Experience managing validation/Test activities for IT initiatives and projects. 10+ years experience - Facilitation of the definition of project mission, goals, milestones, tasks, deliverables and resource requirements- Developed and maintained project plans, status reports, issue logs, and other project-related artifacts
• IT Management or an IT Associate for a number of local pharmaceutical and manufacturing companies. Chaired Computing Committee for Confidential R&D group- liaison between R&D and Corporate Computing.
• Built a complete validation program at Confidential - implementing a validation compliance program for Confidential .
• This included development of the full Development Life cycle Documentation (SOP'S)
• Writing protocols for the implementation of actual testing.
• Process Validation- Establish and validate processes related to development of medical devices and quality system programs.
• Gathering user requirements for Functional Requirements Specifications, System Design Specifications, Master Validation Plans, Trace Matrices, Test Plans, Factory and User Acceptance Testing, experience handling Validation Exception reports (discrepancy/deviations) documentation. risk assessment, remediation, and implementation of validation compliance. Validation Modeling, Trending, Statistical analysis.
• Experience in Audit change management system for adherence to policies and procedures.
• Experience in provide computerized system validation, manufacturing, production and development systems, consultation and evaluation.
• Experience in advising and supporting IT and management with respect to regulatory compliance- Effectively communicating project status, issues, schedule and s to various management and stakeholder groups, as needed
• Experience the IT department to applicable quality and compliance policies and procedures- Built coalitions among the various stakeholders and negotiates authority to move the project forward extensive IT project management experience. Experienced working in a customer service environment. Experienced in metrics determinations
• Knowledge of FDA regulations and guidelines, including cGMPs, QSR Confidential 13485 and 21 CFR Part 11; and experience developing policies and procedures within a technical environment
• Computer Systems Validations (CSV) Implemented QA/QC Software Test development. Software/Hardware development Life Cycle (SDLC) experience. Developed and executed FAT, DR, IQ, OQ, PQ and DQ, MVP, Test plans, validation procedures, commissioning and decommissioning and manual/automated testing of applications
• Implemented User Requirements Testing, Site Acceptance Testing, and Factory Acceptance Testing for applications and equipment. Experienced in IT/laboratory equipment commissioning. (Includes third party application Validations)
• Experience in Change control, documentation version control, investigations, risk assessment, regression testing, root cause analysis, investigations and CAPA.
• Supervise the activities of contractors, lab supplier/vendor assessment to Quality Agreements
• Former experience in instrument calibrations.
• GAP Analysis
• Supported LIMS SYSTEMS: LIMS support, management and development experience- Beckman, TurboChrome, Waters, Starlims, Empower, LabWare, Nugenesis. Validation of large systems.
• Experience with eDocs, Moodle, Documentum, Interleaf and Xerox, Sharepoint, document control systems
• (Developed in-house Doc control system for two former employers)
• Developed and implemented internal and external audit procedures. Developed vendor audit process for manufacturing control. Validation documentation audits, vendor and customer audits for compliance and verification of for for field techs
• Built Quality Systems, Validation and Document Control programs from ground up.
• Confidential 900x experience, IEC/UL/ES 60601-1 exposure, Confidential 13485 experience, FDA (Title 21 CFR 11, 58, 210, 211, 820), ICH guidelines, and Confidential 900x under Kema)- exposure to EU and Canadian regulations), 510K submissions, CE Mark submissions
• Experience with SOX, Annex 11, GAMP5/6, EU regulations related to CE marks and regulatory compliance. Developed Corporate Quality systems from ground up.
• Hospital laboratory, clinical research experience, 10 years experience in research environment. Pharmaceutical research/QA associate Baxter Travenol Miami, FLA, numerous hospitals. Experience in blood and plasma facilities working directly with laboratory personnel in the process of blood and plasma products. Laboratory experience includes hands on Blood banking, hematology, Microbiology, Bacteriology, virology, pathology (autopsy assistance), and clinical chemistry. Performed scale up of R&D project to manufacturing environment.
• Liaison between Technical Development groups (Chemical, Analytical Development, QA, Production Research and Development ~400 scientists and staff ) and corporate IT, coordinating office and laboratory projects.

PROFESSIONAL EXPERIENCE:

Confidential

Quality Associate

Responsibilities:

• Built and implemented Validation program as part of QMS for in-house and third party specifications for validation of third party built components (hardware and software)
• Completed build of Quality System documentation, due to company downsizing earlier in year
• GAP Analysis of existing environment to comply with Confidential 13485 and 21 CFR 11 Compliance
• Developed Confidential 13485 requirements documents for application for Confidential 13485
• Supported and developed SOP’s for Quality System Audits
• Experienced with 21 CFR 11, ICH guidelines
• Internal development of SOP’s for equipment validations
• Change control, CAPA management, Investigations, OOS, Root Cause Analysis
• Built Vendor Assessment program
• Experienced with 21 CFR 210, 211 (cGMP) in pharmaceutical environment
• Lead FDA compliance and Confidential compliance audits
• Managed writing 510K’s, IND’s, NDA’s, PMA’s, CE Marks
• Development of compliance related to all departmental needs for compliance to Confidential and FDA regulations.
• Validation of equipment- process development and process validation
• Built program for Confidential and cGMP environment in a Medical Device organization
• Trained Management in the implementation and continued compliance to both Confidential and
• CFR regulations and impact on company quality
• Regulatory submission project start to finish for 510K, PMA and CE marking
• Performing QA, RA, Documentation, Compliance, Supplier verifications, CAPA development, and validation

Confidential

Quality Systems Manager

Responsibilities:

• Validation Life Cycle experience with SDLC requirements (i.e.- IQ,OQ,PQ, Functional requirements, Design specs, MVP, Commissioning, Decommissioning, Test Plans, Protocol writing, etc)- Project manager in its implementation
• System testing- hands on testing of software applications built compliant Quality
• Systems based on Confidential 13485 and 21 CFR 820 requirements (One documentation set to comply with both regulations).
• Develop and manage Validation Program for Class II medical devices for facility.
• Development of packaging and shipping validation process for shipping of systems domestically and internationally.
• Experience with 21 CFR 11, 21 CFR 210, 211 in pharmaceutical environment
• Managed Validation Review board
• Developed Quality Systems program from ground up.
• Developed Confidential 13485 requirements documents for application for Confidential 13485
• Supported and developed SOP’s for Quality System
• Audits, vendor, supplier assessments for Quality Agreements
• Internal development of SOP’s for equipment validations
• Lead FDA compliance and Confidential compliance audits
• Developed and managed CAPA compliance, Risk and Compliance assessments

Confidential, Clayton, NC

Laboratory Systems Compliance Officer

Responsibilities:

• Validation of Laboratory QA/QC equipment and processes.
• Managed compliance for entire facility, all laboratory and facility areas, IT, Validation, documentation control, Vendor review, laboratory compliance to SOP, SOP review, development of IT systems, .
• Laboratory systems compliance and administration of LIMS systems (Empower, Nugenesis- reports for lab, management, validation)- quality systems and 21 CFR 11 compliance
• Develop protocols and procedures following the Software Development life cycle, IQ, OQ, PQ, FRS, MVP, SDS, Validation, Commission of laboratory equipment, systems validation (applications)
• Member of the Validation review Board-reviewing all plant validations. Manufacturing and production validation environments.
• Process validation, equipment validation, computer systems validations (CSV) laboratory compliance for 21 Part 11 compliance for laboratory equipment.
• Application development and validation- Database validation, systems validations, laboratory equipment validation, method and process validations.
• Implementation of an assessment program for bringing Laboratory systems into Part 11 compliance within laboratory; assessment, risk analysis, remediation
• Developed protocols and procedures following the Software Development life cycle, IQ, OQ, PQ, FRS, MVP, SDS, Validation, Commission of laboratory equipment, computer systems validation (CSV) (applications)
• Developed 21 CFR 11 ERES Assessment protocol for Electronic Signature Assessments

Confidential, RTP, NC

Regulatory Consultant

Responsibilities:

• Validation of Processes
• Documentation Management- SOP’s, Clinical Lab data, Test Results, Validation Documentation, Equipment Specs, Audit documentation
• Process and method validations
• Validation- Development and execution of laboratory and facility Equipment, Computer (CSV), and process (Validation) documentation, protocols, etc.
• CAPA management
• Audit performance and management- Vendors, internal
• Site specific compliance verification to meet 21 CFR 820, CLIA, 21 CFR 211 (cGMP), Confidential 13485 compliance

Cenduit, RTP, NC

QA IT Systems Associate

Responsibilities:

• Clinical Systems Validation
• Review documentation for initiation of clinical trial studies, IT responsibilities include verification and validation review on clinical trial Computerized IVR Study System.
• Development and management of documentation control system for cGCP GOP’s and forms for Clinical studies. Management ofdocument management system.
• Developed Audit SOP for conducting Internal and external IT audits for IVR Clinical Trial system. Hosting and sponsoring customer cGMP and cGCP audits.
• Conducted compliance audits on internal and external clients for IVR Clinical Trial system. Developed and implementation of SOP’s to support this activity.
• Worked with QA to develop and manage Quality System for Cenduit.
• CAPA/audit management, GOP development and compliance. Data review of CAPA reports- Risk Analysis, root cause analysis, trending of CAPA projects.

Confidential, Raleigh, NC

QA, Validation, IT Mgr

Responsibilities:

• Developed Validation procedures compliant with customer needs within regulated environment
• Implemented and validated IT systems, Hardware/Software (CSV) Validation, Applications and Database development validation and IT Support. Developed procedures compliant with FDA, Confidential agencies (Validation of Environmental Chambers, and SCADA software).
• Integration of Sales, Service and Production systems into SQL server- implemented validation procedures for this application.
• Established and chaired validation review board, supported Quality System to IT requirements
• Developed and validated Document management/tracking system.
• Responsible for generation of IQ, OQ, PQ docs for validation of environmental chambers and SOP development and maintenance.
• Developed documentation for pharmaceutical building commissioning, documentation for validation of laboratory equipment- environmental chambers, sterilizers, lyophilizers, and other lab equipment.
• Involved with end user requirements gathering for developing Envirotrac application (FRS, SDS, Test Plans, MVP, Traceability Matrix, change control, etc.).
• Validation Master Plans and protocols for validating Environmental Chambers, commissioning of equipment, and Sterilizer equipment (Some Kaye Validator exposure)

Confidential

Director IT Quality Systems

Responsibilities:

• Supported Software Quality Assurance/Regulatory Compliance/Hardware, Software and Building Security
• Developed and implemented operating procedures for software validation and security.
• Developed and implemented NOTES document management system.
• Call Center, IVR and Web based data collection QA/QC involvement.
• Developed procedures compliant to 21 CFR 11.
• Project Leader for company Y2K compliance testing and verification.
• Participated in end user requirements gathering for developing end user applications (FRS, SDS, Test Plans, MVP, Traceability Matrix, change control, etc.).
• Validation of systems.

Confidential

Senior Information Services Analyst

Responsibilities:

• Supported in house Laboratory Systems (about 120 pieces of equipment), software validation, IT, End Users.
• Project team member for new LIMS system implementation, and a Y2K Project Team member.
• Supported in-house Novell and NT network, supported of in-house PPIS AS/400 system, STL and PCR scientific systems support.
• Project leader for selection of Laboratory LIMS system.
• Supported lab and departmental PC’s, installation and support of plasma tracking system, and validation of tracking application, and laboratory systems.
• Performed statistical analysis of data (SAS). Involved in end user requirements gathering for developing applications (FRS, SDS, Test Plans, MVP, Traceability Matrix, change control, etc.). Responsible for systems and network security.

Confidential

Information Services Manager

Responsibilities:

• Supported Validation activities for Confidential
• Supported Corporate LAN, telephony
• Hardware/Software and end users.
• Responsible for development of Engineering Systems and Databases.
• Project leader for MRP/ERP system selection for company.
• Support of Clean room systems.
• Managed team for selecting a manufacturing information system.
• Participated in selection and implementation of an Oracle based Finance, HR and Marketing systems for company. Implemented Validation procedures for implementation of OTS systems.
• Project leader for selection of MRP and LIMS systems.

Confidential, Morrisville, NC

Information Services Manager

Responsibilities:

• Supported Corporate LAN, Hardware/Software systems and database development.
• Managed phone system.
• Supported of laboratory automation information system,
• Scientific programming for scientific applications. Strategic planning, budgeting, disaster recovery and implementing new systems.
• Supported TurboChrom LIMS system and was involved with statistical interpretation of data
• Supported Validation of equipment and processes.

Confidential

Senior Technical Services Analyst

Responsibilities:

• Liaison between Technical Development groups (Chemical, Analytical Development, QA, Production Research and Development ~400 scientists and staff ) and corporate IT, coordinating office and laboratory automation projects.
• Supported computing needs of TD scientific groups (requests for computer hardware, software and networking needs, trouble shooting).
• Chaired CDL and Technical Development Computer Standards committee.
• Manager/supervisor of CDL Office Systems Administrator and temporary employee.
• Evaluation and introduction of new computing technologies to improve productivity of scientific and research personnel.
• Developed and supported CDL Chemical Structure Drawing Database (ISIS/CHEMDRAW) and document management database system. (Quality Control for laboratory equipment and lab procedures).
• Responsible for the development of chemical structures using chemical structure design applications.

Confidential

Technical Services Analyst

Responsibilities:

• Responsible for end user requirements gathering for developing scientific applications (FRS, SDS, Test Plans, MVP, Traceability Matrix, change control, etc.)

Confidential

Sr Technical Quality Systems Services Analyst

Responsibilities:

• Supported medical device development and submission at Confidential for Class II medical device for hemostatic and thrombotic measurement. Included 510K submission writing and support of Device Master and History Records.
• Information systems validation of Research and development with scientific and management staff.