Paul Knowlton Email & Phone Number

Boston, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

Paris, France, Fr

Developed and executed new procedures for periodic audits of user access for 16 ITS pharmaceutical manufacturing systems and 4,300 system users to ensure compliance with updated ITS SOPs.Corresponded extensively with and offered guidance to system user managers to review user access, verify user training and resolve all user access issues for 100% of the system users.Supported yearly Laboratory Equipment Requalification Assessment project to confirm compliance with newly created Sanofi Quality Control laboratory equipment requalification assessment SOPs.Combined and enhanced ITS SOPs and other documents from the Sanofi Framingham and Allston sites as part of the ITS Document Harmonization project and formatted the documents for migration to GEODE+.

Boston, Massachusetts, Us

Teamed with project managers and software developers to deliver software change requests for Nautilus LIMS and integrated custom applications as required by FDA 21 CFR Part 820 CGMP regulations and internal SOPs.Scheduled meetings with project stakeholders as needed, and shepherded documentation through the Quality System Regulation (QSR) change control process to ensure stakeholders reviewed and approved documentation in a timely manner.Wrote and executed Operational Qualifications (OQs) to validate and verify that software changes met the needs of the stakeholders and complied with FDA regulations and internal requirement specifications. Reviewed and edited Installation Qualifications (IQs) written by software developers to confirm accuracy and adherence to good documentation practices (GDP).Reviewed change control and validation/verification documentation executed by team members for completeness and adherence to GDP.Authored non-conformance reports and test execution incident reports as needed after review of executed documentation, and collaborated with the compliance department to resolve issues.Created and updated work instructions for use by end-users in the FMI laboratories.

Portland, Maine, Us

Designed, developed, and executed test plans and test scripts for desktop and mobile device testing of web-based e-Commerce and digital gifting applications.Leveraged proprietary testing automation software to increase productivity, and for regression testing.Utilized Agile/Scrum Software Development Lifecycle practices to ensure continuous process improvement.Participated with cross-functional team members in daily stand-ups, sprint planning meetings, and sprint retrospectives.Used Jira, Confluence, TestRail and BrowserStack to manage and execute project tasks, report and track issues, and to create, update and store team documentation.Supported monthly production deployment of system enhancements.

Cambridge, Ma, Us

Created and executed test plans and detailed test scripts for web applications according to project timelines, and based on business requirements and technical specifications.Actively participated in developing business requirements and technical specifications with internal and external cross-functional team members from the beginning of the SDLC until all validation documentation was finalized.Published system impact assessments and project quality risk management plans for review by the quality compliance department.Wrote and executed installation plans and installation qualifications (IQs) to ensure successful implementation of software.Identified, logged, and tracked software defects until all defects were fixed or otherwise resolved.Utilized SharePoint and myCIMS to collaborate with cross-functional team members and to route documents for review, electronic signatures, and version control.

Durham, North Carolina, Us

Teamed with project managers and programmers at PAREXEL sites in the US, India, and the UK to deliver software change requests (CRs) for clinical trials on time and as demanded by clients, internal SOPs, FDA 21 CFR Part 11 and GxP regulations.Evaluated requirement specification updates to identify discrepancies with the corresponding clinical trial CRs, to recommend process improvements and other modifications if necessary.Completed Installation Qualifications (IQs) to ensure software met specified requirements and was properly programed and installed.Created and executed test plans and traceability matrices to confirm clinical trial CR amendments worked as intended, and to regression test surrounding system functionality and relational database updates.Utilized BugZero to track software defects until resolved with programmers and project management team.Reviewed test scripts written by validation services and project management staff to provide guidance and to verify completeness and accuracy.Created and updated Visio call flows according to client specifications to ensure efficient CR development and timely implementation.

Us

Executed acceptance testing and provided for PFPC and AOS largest full service mutual fund transfer agent (TA) client. Ensured accurate and complete data transmissions from SuRPAS systems and cooperated with systems staff to resolve data transmission issues. Assisted print mail operations to resolve timely production issues concerning trade confirmations, checks and periodic statements. Coordinated and directed medium and small size projects involving three PFPC proprietary mainframe TA systems (SuRPAS, FSR and PAR). Identified and documented project issues and resolved problems by working with AOS and TA programmers and operations staff. Maintained relationships with AOS clients via phone, fax, e mail, and on-site meetings. Carried out acceptance testing to support the design, development, implementation, and maintenance of mainframe and windows applications. Collaborated with BSAs, programmers, and end users to identify and evaluate requirements for testing new software and software enhancements. Developed test plans that ensured software changes will work as they are designed to, and do not adversely affect existing system functionality. Executed test cases by manually executing trades, maintaining online screens, and reviewing output to verify its completion and accuracy. Projects included large client conversions from competitors TA systems, fund mergers, and online enhancements. Prepared weekly status reports throughout the life cycle of each project referral.

Us

Monitored daily NSCC transmissions and resolved rejected and exception items utilizing PFPC mainframe TA systems (PAR and FSR). Interacted daily with PFPC clients and broker/dealers via telephone, fax, and e mail to resolve Fund/SERV and networking problems. Trained new and less seasoned individual contributors to bring them up to speed and helped them resolve complex problems. Teamed with PFPC proprietary systems personnel to identify systems and NSCC interface breakdowns and implement solutions. Utilized telephone contacts at the NSCC to ensure accurate transmission of trade and networking data. Cooperated with PFPC departments such as Broker/Dealer Support, Management Company Support, and Control to identify and resolve issues. Executed daily settlement responsibilities for PFPC clients utilizing PFPC developed windows based software and mainframe systems. Reconciled demand deposit accounts using Excel and Lotus 1-2-3 spreadsheet software and Microsoft Researched and resolved issues involving shareholder accounts utilizing PFPC mainframes and internal and external contacts.