Paul Marasco Email and Phone Number

Responsibilities include gathering of test requirements, creation of validation test plans and project scheduling for electro-mechanical testing devices and test methods for laboratory diagnostic components. Collaborate with R&D and support the commercial supply chain in development of validation protocols and reports for testers, while assuring project deliverables are attained on schedule.Work with third-party suppliers on tester development and procurement, including Request for Quotation submittals and process change documentation (impact assessments, change plans and summary reports). Manage cross functional teams in negotiating vendor quotations and preparing material requests to support project deliverables.

Responsible for support of production operations, implementing cost and process improvement projects and modifications to enhance performance of existing products (Class I and Class II devices). As owner of Site VMP, play a lead role in managing validation projects, new equipment qualifications, process validation, change control and scheduling within system life cycle in adherence to corporate, GMP and regulatory standards / guidelines (including FDA Quality System Regulation 21 CFR Part 820 and ISO 13485 Quality Standard). Revise site SOPs, Work Instructions and Test Procedures, while overseeing the approval process and training.Worked with teams on integration to GEHC’s Quality Management System in 2011 (Vital Signs was part of GE Healthcare from 2008 - 2013). Perform impact assessments relating to production non-conformances and equipment/instrument issues; use TrackWise® tool to address non-conforming product or processes, investigations and CAPAs. In late 2012, validated a new extrusion line for expandable hose to meet market demands. In 2013, qualified same new extrusion line for the production of pediatric expandable hose and qualified / validated a new extruder to convert an existing line to manufacture Dual Lumen (Limb-O) hose.

Responsible for remediation and completion of Quality Notification Investigations and related activities to address/remediate regulatory GMP compliance gaps at a major Canadian pharmaceutical company.

Same as previous.Wyeth formally become part of Pfizer on Oct. 16, 2009.

Managed analytical instrument qualification projects for the Metrology team within the Validation Department, supporting Quality Control (QC) laboratories and vaccine production operating units. Provided pre-requisite planning, scheduling, monitoring of timelines and status on qualification/validation projects. Oversaw revised validation procedures in conjunction with a Lean Six Sigma / Process Improvement project that resulted in greater than 50% reduction in time/labor required to qualify critical laboratory instruments. Reported on project lifecycle validation status and collaborated with team members, customers and Quality Assurance (QA) to proactively drive cross-functional activities between departments. Reduced supervisor’s workload by providing daily progress tracking and status updates on multiple projects, reporting critical path issues and anticipating potential roadblocks. Served as department representative on site Safety Committee, conducting departmental safety audits, training, and awareness sessions.

Managed validation projects, requirements and deliverables, project planning, established/ coordinated cross-functional teams and project timelines within the Technology Dept. to support the site Validation Master Plan. Supervised subordinate project managers (3) in daily activities. Ensured adherence to clearly defined job scopes, plans, roles and responsibilities. Recruited, selected, evaluated performance and provided training for department staff. Ensured staff proficientcy in cGMPs, safety and departmental procedures.Resource management: schedule employee and contractor work, ensuring timeliness of validation training.Ensured that project deliverables are met by obtaining requirements and list of deliverables for each phase of the project life cycle.Reported validation metrics, compiled project timeline/ completion rate data, identified trends and prepared impact assessments. Alerted management of potentially high risk situations that may impact business or products.In 2008, was nominated and assumed Regulatory Project Manager role for Wyeth’s first ever electronic document submission package for European and US market approval of company’s improved pneumococcal vaccine product, Prevnar 13. This represented the largest product filing in US history. Worked with authors, reviewers and approvers, including QA and Regulatory Affairs, at various sites to manage document lifecycles. o Played lead role in the successful preparation, review and final approval of validation documents and reports from department, representing over 25% of completed deliverables for Pearl River site.o Communicated open items and issues to lead Project Manager to mitigate delays, and streamlined efforts to ensure adherence to an aggressive schedule. Key contributor to customized MS Excel application that tracked and monitored validation projects, providing real-time project statuses, alerts to milestone / due dates, and automated reporting and VMP revisioning.

Project Manager supporting validation activities for Polysaccharide production (the 7-Valent Streptococcus pneumoniae used in the processing of Prevnar Pneumococcal Conjugate Vaccine). Responsible for scheduling, monitoring and reporting on validation projects including metrics reporting, compilation of project timeline/ completion rate data, identification of trends. Retained this responsibility while taking on new, additional responsibilities upon promotion to Manager in May 2005.

Performed audits within Consumer Health division to assure that a high degree of regulatory cGMP compliance exists within site production practices and operations, including training, SOP adherence, validation activities, environmental and HVAC systems (supporting Centrum vitamins and other dietary suppliments).Prepared written reports to manufacturing, QA and senior management, reporting audit results, compliance risks, and recommendations for corrective actions. Monitored corrective and preventive actions (CAPA) for acceptability and sustained compliance, and reviewed FDA publications and FDA 483 audit reports from other sites to ensure site adherence to regulatory standards. Assured operational controls and remediation activities were established as a result of regulatory observations, deviations, out-of specification (OOS), and out-of-tolerance (OOT) trending conditions. Generated and exported TrackWise® (web-based tracking system) reports to appropriate personnel. Improved site performance on regulatory inspections through written reports and reporting of housekeeping issues to senior management and site Quality Council. Identified / addressed deficiencies in metal detection practices on packaging lines, leading to the development of improved processes enhanced procedures modifying SOPs to and ensure GMP compliance. Acted as liaison between manufacturing and QA to resolve issues and promote compliance with internal and corporate procedures.Assessed compliance and business risks to senior management, and recommendations for corrective actions to manufacturing and quality assurance. Presented monthly audit reports to site Quality Council and supplier audit summaries to Material Review Board to facilitate material sourcing decisions.

Responsible for ensuring that site SOPs, along with related knowledge assessments and job aids, complied with current cGMP, cGLP, corporate policies, quality and regulatory standards. Reduced QA backlog in response to Consent Decree. Reviewed, revised and approved SOPs and related documents to enhance clarity, accuracy and adherence to general methods and USP/NF guidelines.

[Vertek is a provider of service life cycle business process outsourcing, consulting and managed technological and business solutions within the communications industry.] Responsibilities included gathering of business requirements and initiating software development of new features and enhancements for telecommunication provisioning systems, utilizing SDLC methodology. Authored and maintained a Business Rules repository for Vertek’s MDS (Minimum Data Set) application created exclusively for AT&T. This internal document was used for technical support, training, QA testing and customer order reference. Developed requirements for AT&T’s MDS application, a web based order provisioning system. The application created and submitted orders, calculated pricing/billing, and generated contracts online. Hosted by Vertek, this served as AT&T’s flagship IP ordering system, supporting over 5000 direct sales reps and another 6000+ Authorized Agents over its 3 year run. Product suite consisted of a variety of managed internet services. Performed ORACLE database queries in response to client requests and research gathering. Proficient at migration of this data to MS Excel to generate reports. Performed data warehouse activities to create daily and weekly reports for client.Consulted with clients to define business requirements, achieve project objectives and offer workable solutions within our web applications. Acted as liaison between clients, development teams and infrastructure in resolution of technical problems and data compilation issues; achieved success with diagnosis and fault isolation. Coordinated and identified required actions to satisfy business needs, and to explore alternative methods to resolve issues. Involved in formulating estimates for new development in response to a changing IP sales environment. Maintained focus on current issues relating to business needs while keeping client appraised of status.

Performed QA work on various web-based order generation and provisioning systems serving major telecommunication providers and their customers. Ensured applications enforced business rules to confirm proper order entry, status updates, and client privileges/security to effectively provision Private Line, Frame Relay, T1/T3 and other services.Web-based testing of GUI functionality, including unit, system and integration testing, and writing / execution of test cases and scenarios. Performed regression testing, white box / black box testing, and positive / negative testing. Major role with integrated end-to-end testing of AT&T’s IP Order Provisioning Systems. Created, submitted and released test orders to validate systems integration and transfer of data within Oracle RDBMS environment. Analyzed results and provided reports to ascertain whether required business objectives were met. Supporting customer sales teams, prepared documentation on IT systems, including business process flows, provisioning intervals, workload distribution, metrics reporting, and customer satisfaction/feedback. Analyzed, presented and reported data for a benchmark study of telecommunications industry services. Technical writing efforts documenting web-based ordering system evolved into a dual QA role to certify system functionality and adherence to business rules. Authored and maintained Business Rules and User Guide documents for web-based applications, used for technical support, training and QA testing.

[Aero Tec Laboratoies is a manufacturing, research and design company producing flexible composite materials, engineered inflatables and crashworthy fuel cell bladders serving the automotive racing, environmental, defense and aerospace industries.]Reporting to the President and Director of Research & Development, managed and completed largest monetary contract (c. $2M) in company’s history. Part of R&D team, assumed lead role for this new project with Lockheed Martin and NASA. Responsibilities: engineering design and development, technical analysis, scheduling, manufacturing, and quality control. Project deliverables: customized specialty-rubber bladders for water storage used to dissipate heat in space suits during EVA (Extra Vehicular Activity) on shuttle missions and assembly of International Space Station. Efforts resulted in over 12% of 1996 annual sales; achieved financial and contractual milestones ahead of schedule. Prepared and presented Preliminary Design Review (PDR) and Critical Design Review (CDR) to Lockheed and NASA clients in Houston, TX. Additional duties included writing of monthly status reports, and creation of standardized assembly and cleaning procedures, test plans and QA data packages. Lockheed project success led to a related order from NASA to produce customized diaphragms of the same specialty fluoroelastomer rubber for use in the X-38 ISS Crew Return Vehicle (CRV). Researched and selected a Value Added Network to establish Electronic Commerce/Electronic Data Interchange (EC/EDI) to receive government solicitations, Request For Quotes (RFQs) and submit bids for orders via the Federal Acquisition Computer Network (FACNET).Other work involved preliminary design work using CAD and rotational molding technologies for alternate fuel concepts and expulsion bladder tank prototypes for spacecraft propulsion systems.

[A manufacturer of inertial guidance and measuring systems serving primarily the aerospace and defense industry (a subsidiary of Astronautics Corp. of America, and formerly a division of the Singer Co.).]Performed engineering support functions, analysis, troubleshooting/fault isolation, repair and test of inertial guidance and measuring systems for military aircraft. Identified current and potential problems through analysis of test results to identify failure trends and corrective actions on various programs (F-16, SR-71 Blackbird, B-1B, C-5A and Trident MK6 missile). Partnered with QA to investigate system performance issues, providing remediation and rework support. Achieved cost savings objectives by revising repair methods and procedures, resulting in 25% decrease in test failures and associated gyroscope alignment rework. Played key role in streamlining of workflow and delegation of project tasks to improve existing processes. Initiated and provided instructions to machinists for repair of damaged circuit cards received from field. Provided drawings and written dispositions to ensure quality repair and functionality following rework. Trained subordinate engineers and a visiting team of engineers and technicians from Norway on troubleshooting and repair of the F-16 gyroscope system, assuming technical leadership responsibilities.