TECHNICAL SKILLS:

Medical Device:   System Regulations, GAMP, GxP, SOPs, SLA’s, SOW’s, Test Plans, QA Plans, OQ/IQ/PQ, FDA 21 CFR Part 11, 50, 54, 56, 312, 314, 510, 812, 814, 210 Compliance, GxP, cGMP and cGLP, Audits, SOPs, Clinical Trial Systems, HIPAA Compliance, Audit EDC records, IEEE, ISO 9001, ISO 13485, ISO 17025, ISO 14971, Validation, IQ, OQ, PQ, CAPA, Risk Management

Environments: Client - Server, PC (XP, NT, 2000), UNIX, .NETOS/2, and HP 9000, Mainframe IBM and HP, Sybase, Oracle, SQL Server, ASTM E2500

Testing Tools: Quick Test Pro, Mercury Quality Center, Load Runner, Rational, Data Profiling Tools, SOAPUI, TrackWise

Software: Service Now, LIMS, Documentum, Business Works, Q&E Query Tool, MS Access, Convera, Epicentric, Rational Test Tools (Requisite Pro, ClearCase, ClearQuest), Tracker, Crystal Reports, MS  Office Tools, Microsoft Project, Visio, Case Tools, Database Tools, HP (Mercury) Quality Center, Facets, VMWare Desktop, QSI, Sharepoint, PeopleSoft, Hogan, Allscripts, McCormick Dodge, Risk Management Plans, SAS, SaaS, Discoverant 4.0, Labware, Starlims, Wavefront, Lablynx, Infosario

Methodologies:   GAMP-4/5, Sarbanes-Oxley, RUP, CMM, SUMMIT D, ISO, IEEE, customized SDLCs, V-Model, SAP, Agile (Scrum and SOAPUI), Summit-D, ITIL, Storyboarding, Use Cases,

Regulatory Leader 

Responsibilities:

• Demand Review Process; including dealer and inventory forecasting.
• Supply Review Process; using an unconstrained Heuristic to plan for the global supply model.
• Finance Modeling; ensuring a financial model of the Sales and Operations Planning processes.
• Collaborative planning using the SAP JAM functionality for collaborative Integrated Business Planning.
• Integration via the SAP HANA Cloud Integration software. Using Rapid Deployment Solutions.
• Technical Environment: SAP IBP v4.0

Foster City, CA 

Senior Regulatory Compliance Consultant 

Responsibilities:

• Provide Quality Oversight of Validations and responsible for reviewing and providing guidance to the project team on validation efforts and ensuring that the quality system is maintained and compliant to current regulations. 
• Responsible for ensuring that the Regulatory Compliance department maintains a defendable “Quality System”
• Responsible for working with the management team to determine the pros and cons of risks that have been identified based on overall compliance with a “risk based approach”

Durham, NC

Senior Consultant

Responsibilities:

• Validation Team Lead on Site and leading remediation and compliance improvement activities for large International Pharmaceutical and Medical Device companies with FDA Consent Decree, Warning Letter, and 483 abatement needs.
• Responsible for conducting Third Party biweekly meetings between us and the client.
• Responsible for conducting risk assessments for each medical device line and presenting the findings along with a plan of mitigating the identified risks.
• Responsible for creating risk tables that were used as a template for evaluating risks.
• Responsible for creating reports and presenting to senior management on regular basis.
• Responsible for providing SME review and creation of process and equipment validation protocols for manufacturing processes.
• Responsible for making sure the operational qualification reports are complete for Quality sign-off.
• Responsible for implementing Discoverant and providing ongoing site support with analyzing the data.
• Responsible for compiling labware data for stage processing.

Medina, NY

Senior Consultant

Responsibilities:

• Support of the development, completion, logging and archiving of documentation on protocols, Validation Master Plans, and Validation Summary Packages for automation/controls and computer systems
• Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines
• Support continuous improvement within the quality department
• Support regulatory submissions and regulatory agency inspections as required for automation and control system qualification.
• Overseeing of the qualification process for all related automation and control project implementations involving PLC and DCS systems, along with MES/EBM systems in addition to supporting the change control process for all related software changes.
• Represent company validation department to industry as required
• Serve Tier 2 Work stream teams as required
• Responsible for making sure that “Risk Analysis” assessments were performed for 510K deliverables.
• Responsible for day-to-day support of the Automation and Controls CQV Program.
• Responsible for SAS validation and compliance with respect to assuring that the data was clearly analyzed and adhered to the change control policies and procedures.
• Duties include the execution of validation processes to ensure the control systems meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices.

Durham, NC

Senior Consultant

Responsibilities:

• Responsible for developing a system(s) that will enable the manufacturing and information technology organizations to interact in a formal way that allows items to be tracked and monitored.
• Responsible for applying “Lean Six Sigma” principles and drive process improvements that will result in better efficiency and cost-savings.
• Serve as a subject matter expert (SME) for the Demand Management division for various projects and recommend solutions.
• Serving as a subject matter expert (SME) for the training department (SRO).
• Assist with developing standard operating procedures.
• Responsible for developing staff and working with internal departments to make sure that compliance is met and in accordance with regulatory standards.
• Opened, tracked, and closed deviations.
• Responsible for gathering Discoverant data and formalizing the information for senior management.
• Work as a liaison with various departments for on behalf of the Training Department.

IT SQA Clinical Trials Leader

Responsibilities:

• Responsible for managing staff of 17 technical personnel that validate and test systems used by the clinical trials organization.
• Responsible for managing, coordinating, leading and developing the direct to meet company, department and individual objectives.
• Ensures continuous improvement of staff’s performance through training, coaching, mentoring, and providing timely and accurate performance measurement.
• Ensures development of project plans, evaluates risk, and coordinates resources to meet requirements around product and software releases.
• Responsible for ensuring that SAP releases are validated and tested before being deployed into the production environment.
• Serve as subject matter expert on the Acquisition Team during all company acquisitions.
• Serve as SME for Discoverant installation and making sure that the application was compliant with the current corporate quality system.
• Responsible for the SAS migration to SAS 9.2 and moving the legacy system(s) to the new windows platform. This effort also included validation and compliance.
• Responsible for tracking and closing deviations on behalf of the site and ensuring that all paperwork is centrally located in the event of the audit.
• Ensures development and implementation of effective strategies for managing the processes, systems and tools necessary to produce solutions that meet or exceed customer requirements.
• Responsible for creating and managing departmental budgets.
• Responsible for managing 9 “Offshore” resources in conjunction with 8 fulltime reports.
• Responsible for making sure that the company remained in compliance to ISO 14971 standards.

Greensboro, NC

Executive Regulatory Consultant

Responsibilities:

• Responsible for providing FDA guidance as they are now being governed by the FDA.
• Responsible for developing policies and procedures around current processes and recommending industry best practices.
• Responsible for auditing external and internal clients for compliance to current policies and procedures and making recommendations based on the overall assessments.
• Responsible for keeping abreast of the regulations and the changes with the intent on understanding the impact to the business and defining what course of action needs to be taken to remain in compliance.

Winston Salem, NC

Executive Regulatory Consultant

Responsibilities:

• Responsible for providing FDA guidance as they are now being governed by the FDA.
• Responsible for developing policies and procedures around current processes and recommending industry best practices.
• Responsible for auditing external and internal clients for compliance to current policies and procedures and making recommendations based on the overall assessments.
• Responsible for keeping abreast of the regulations and the changes with the intent on understanding the impact to the business and defining what course of action needs to be taken to remain in compliance.
• Responsible for maintaining current ISO certifications for compliance.

Global Leader of QA Validation

Responsibilities:

• Proposed, obtained buy-in, and implemented a GAMP4/5-based computer systems validation program appropriate for global execution.
• Responsible for ISO 14971 adherence.
• Implemented a “Deviation Management Program” for the site and ultimately held accountable during inspections.
• Responsible for SAP Master Data Management (MDM) implementation and maintenance.
• Served as the SAS Project Leader for the validation of SAS for all North and South America roll-out phases which consisted of 13 sites.
• Responsible for leading the IT and computer system validation governance committee efforts to establish a consistent and common approach to validation globally.
• Developed and executed the quality and validation plans for all computer systems implementations, ensuring timeliness, accuracy, and completeness of efforts and related deliverables.
• Monitored, assessed the impact of, and integrated international and US Federal rules and regulations that apply to computer systems in the pharmaceutical industry.
• Lead the creation, consensus building, and publication of policies, procedures, standards and guidance aimed to ensure the effective and efficient procurement, implementation and use of application software.
• As a function of computer systems validation change management, evaluated proposed changes and managed re-validation activities, as required.
• Supported internal quality and supplier audits, and reported findings to the executive staff.
• Ensured effective training on the GxP computer systems validation program to all employees.
• Set, Managed, audit for Corporate Validation Standards.
• Labvantage coordinator for R&D organization.

Raleigh, NC

Validation Director

Responsibilities:

• Clients (GSK, Invitrogen, Biomerieux, SAIC (Federal Government), ABL, Aderan Labs, Pfizer, Medimmune)
• Trained the FDA field agents on what to look for in the private sector in regards to compliance.
• Responsible all aspects of computer systems validations, equipment validations, laboratory validations, and cleaning validations from a hands-on approach and a management approach
• Performed validation activities for the Live link DMS system. Developed and executed DS, URS/FS, IOQ and PQ documents
• Performed validation activities for the Blue Mountain Calibration system. Developed and executed DS, URS/FS, IOQ and PQ documents
• Project Manager for entire facility startup
• Managed a team of 40 contractors and 20 clients to facilitate the start-up of a new Vaccination Pilot Plant
• Facilitated weekly cross-functional meetings and developed meeting minutes with reports of timelines and deliverables that were due from week to week.
• Responsible for writing, executing, and summarizing Test Method validation protocols

Raleigh, NC

Director of QA Validation

Responsibilities:

• Responsible for developing and implementing in-house validation Standard Operating Procedures
• Responsible for quality control and submissions to the FDA for equipment and system administrations
• Served as the final approval for all validation documentation and submissions.
• Wrote & Executed: Software Life Cycle, Standard Operating Procedures, Validation Test Protocols, Test Cases, Unit Test Scripts, Test Reports, Software V&V Plans, weekly Change Control Requests and Reports, Software Validation Progress & Problem Reports, third-party Vendor Evaluations

Durham, NC

Information Technology Consultant

Responsibilities:

• Consulted to the State of NC on PM offices
• Served as Project Manager for the following departments IRM, DHHS, Medicaid, ITS.
• Assists in the evaluation of client area application systems requirements and processes, in the preparation of application system specifications, and in the development, testing, and implementation of efficient, cost effective application solutions.
• Work with client management to identify and specify business requirements and processes for diverse development platforms, computing environments, software, hardware, technologies, and tools.
• Devise data verification methods, adopts system test practices, and participates in systems testing and documentation.
• Perform system trouble-shooting.
• Analyze existing system and program logic to provide more efficient operations or to identify difficulties.
• Participates in evaluation of utilities, tools, and applications.
• Actively involved in the Building Management System validation.
• Member of the Computer Validation Template Committee and SOP Committee.
• Develop SOPs and Guidelines/Policies.

Scotch Plains, New Jersey

Technical/Project Manager

Responsibilities:

• Provided end-user support for configuration of software and hardware for system compatibility.
• Handled various system problems via modem, on-site and telephone, AS400 system maintenance.
• Assisted in troubleshooting various network communications using tracert, ping, arp, and netstat.
• Responsible for technical requirements for upcoming divestiture which required movement of resources and development needs.
• Used diagrams such as data flow diagrams, functional decomposition diagrams, and entity relationship diagrams.
• Served as a technical resource for qualification and validation activities for our regulated clients.

Charlotte, NC

Management Development Program

Responsibilities:

• Rotated through different area of banking developing customer service skills and utilizing research skills for accuracy in bank processes.
• Served as a “Stock Calibrator” for chief stock brokers as trades were made on the New York Stock Exchange.

RTP, NC

Internship/Co-op

Responsibilities:

• Prepared requirement specifications and helped in detailed design of the database files.
• Conversion of the needs into technical specifications and creation of the database files.
• Generated weekly, monthly reports based on the requirements
• Interacted with the end user in collecting the requirement
• Designed screen layout for the system
• Wrote Java classes and functions.
• Implemented code in Java for application functionality.
• Participated in implementing the system.
• Developed context sensitive help for users
• Prepared Unit specification for the module and performed unit testing.
• Documented the Design Document and was involved in creation of the detailed user Documentation.
• Supporting the Customers with various problem issues.
• Designed and developed the High Level & Detailed Test Plan using standards. Developed the Function Test plan and Test scripts for the Client /server Application.
• Conducted the Functional, System, Integration, Regression, performance, UAT and Smoke Tests of the client server.
• Implementing the releasing plan and risk management in the project, ensuring the highest quality standards for development and services in the Application. Sending the reports to all team members with Daily Status, to track the update in the Testing.
• Designed and developed the High Level & Detailed Test Plan using standards.
• Developed the Function Test plan and Test scripts for the Client server Application.
• Developed computer software and hardware validation protocols for a manufacturing inventory control system (BPCS, AS/400 platform)
• Responsible for preparing validation documents for the Warehouse, Planning, Manufacturing, QA, and Distribution modules
• Provided consultation on GMP and MCA requirements
• Developed and executed protocols for solid and liquid oral dosage manufacturing equipment, PLC controlled processes, and software applications, including USP DI water system, energy management distributed control system, liquid packaging lines, inspection systems, and controlled tablet presses
• Setting up Lab environment for the Testing team by installing the Automation tools, setting up the Application on the different machines for UAT Testing. Training the users in the Lab Environment for Testing the Application.
• Developed the performance test scripts in Mercury for the Applications.