James Joy Email & Phone Number

Collaborate with lab scientists to develop user requirements, act as liaison with IT to interpret user requirements, and test software against user requirements for clinical trial data analysis and LabWare LIMS software. Write qualification/compliance documents (Validation Plan, User Requirements, IQ/OQ/PQ Protocols, SOPs, Acceptance Criteria reports) for vaccine clinical trials laboratory. Includes Hamilton, Tecan, Bravo robots and associated custom methods, Mettler balances, Sartorius balances, Tecan HydroSpeed plate washers, Orion pH meters, Molecular Devices SpectraMax Luminescence plate readers, BioRad BioPlex luminescence readers

Rochester, Ny, Us

I had QA / Regulatory responsibilities for ensuring medical devices met US FDA (21 CFR 820, 21 CFR 1010, 21 CFR 1040), Canadian, Australian and European regulations. Authored 510(k) for a laser based medical device (K080788). Additionally, performed internal auditing and ensured compliance with ISO 9001, 13485 for CE marking.• Ensured HIPAA compliance by creating pertinent policies and procedures, trained company personnel and conducted subsequent internal audits for adherence to procedures.• Authored US FDA 510(k) submission (K080788) for VivaScope® System in compliance with 21 CFR 800 series for medical devices and 21 CFR 1000 series for electronics and lasers (1010, 1040)• Hosted a voluntary 5 day on-site FDA inspection as part of FDA’s Accredited Persons Inspection Program.• Wrote auditing outline and performed company audits on FDA, European (MDD) and Canadian regulations.• Prepared for and hosted external surveillance audits to maintain CE certification including ISO 9001 and ISO 13485.• Prepared annual reports for US FDA (laser safety, annual registration) and Health Canada (annual product registration).• Provided regulatory support for sale of product to several countries including European Union, Canada, China, Russia, Israel, Thailand, Turkey and Costa Rica.• Maintained quality system and implemented updates following periodic changes to regulations.

Authored Change Control and CAPA policies/procedures for clinical site in response to an FDA 483.

• Provided customized training on software validation practices, 21 CFR 11 and risk assessments• Performed cGMP/21 CFR 11 audit of clinical trials computer systems• Designed and performed computer validation on clinical laboratory instruments• Performed cGMP/21 CFR 11 audit on a pharmaceutical manufacturing SAP system.• Developed a validation strategy for a QSI WinLIMS implementation. Wrote/executed LIMS validation protocols.• Performed validation testing for SQL*LIMS implementation.• Authored quality management plan for Pfizer’s industry leading SAFE (Secure Access For Everyone) initiative to provide legally binding electronic signatures to regulatory documents.• Performed system gap analysis against SAFE standards and FDA 21 CFR 11 regulations.• Documented system processes for eventual translation into SOPs.

New York, New York, Us

• Created and implemented a global regulatory compliant software development environment for a multi-department bioanalytical service with 100+ employees. Directly supervised a staff of seven to integrate scientific applications and information management systems in the laboratory.• Installed and validated laboratory plate readers and colony counters consisting of the lab equipment, proprietary vendor software, PC and server.• Integral team member responsible for gathering/documenting user/system requirements for enterprise Electronic Document Management System.• Authored and implemented SOPs for computer software life cycle management.• Designed and delivered a laboratory sample barcoding solution to automate clinical sample management.• Upgraded custom data analysis programs expanding use to clinical/pre-clinical applications. Led projects validating and transferring data to new, compliant software.• Key team member for 21 CFR part 11 risk assessment and remediation planning for Wyeth Vaccines Research. Interfaced with consultants for risk assessment and supplied remediation plan for bioanalytical services laboratory.• Managed project for new custom clinical specimen management system from design requirements, development, validation to implementation insuring 21 CFR 11 compliance and meeting timelines for integration with new Oracle Clinical software.• Conducted vendor audits/evaluations for outsourcing custom software design and purchasing off-the-shelf software.• Supervised statistical quality control and data management services for bioanalytical service laboratories.• Participated on two Pre-Approval Inspection teams providing data management and computer validation expertise for new product application to the FDA. Documented current processes ensuring data integrity for submission.• Ran a pilot program for customizing a LIMS for the pre-clinical laboratory and prepared a proposal for funding a full implementation project.

Bridgewater, Nj, Us

• Warehouse robotic picking - Prepared validation and test plans against functional requirements, noted discrepancies, led corrective action team and wrote validation reports.• Clinical trial system upgrade - Prepared year 2000 compliance protocol, wrote validation protocols for data migration and functional testing and prepared validation reports outlining test results, failures and corrective actions.• Warehouse lot traceability - Worked with client to prepare functional requirements, wrote project management, quality assurance and validation plans, wrote and executed validation protocols, prepared corresponding reports and updated project timelines.• Laboratory equipment tracking system – audited validation plans and results for compliance to standards.• Complaint handling system upgrade – Prepared year 2000 compliance protocol, evaluated functional requirements, wrote validation plans and protocols and prepared validation report

Team member responsible for system upgrade of LIMS LabManager client/server.• Performed project management functions for LIMS upgrade project.• Interviewed current system users to prepare functional requirements.• Wrote and executed system validation protocols/reports on component parts of LIMS system.• Worked with the Information Technology department to develop necessary SOPs.• Performed enhancements and modifications to the current LIMS system.• Trained new users on current LIMS system. Developed and modified applications according to user specifications.• Performed project management functions for PC/instrument interfacing project to record production line data and produce reports.• Performed computer systems validation on PC systems to comply with FDA standards.

B.S.

M.S.