Gerald Jacques Email & Phone Number

United States

Rahway, New Jersey, Us

• Collaborated with cross-functional teams to troubleshoot and resolve validation issues, enhancing efficiency.• Developed and optimized validation protocols for new and existing equipment to ensure compliance with industry standards.• Authored and executed Change Control documents in adherence to Regulatory GMP requirements.• Documented validation activities and results in detailed reports for regulatory audits.

Irvine, Ca, Us

• Reviewed and approved supplier PPAPs to ensure quality standards were met.• Conducted root cause analysis to implement corrections for non-conformities related to supplied components.• Developed inspections and test methods to verify product conformance and improve Supplier Quality system performance.

Bloomington, Indiana, Us

• Applied accurate TMV standards to legacy products to adhere to EUMDR requirements.• Authored and executed a full suite of validation documentation which included: Installation / Operational / Performance Qualification (IQ/OQ/PQ) and Test Method Validation (TMV) Protocols, Summary Reports.• Generated Computer System Validation (CSV) Functional and Configuration Specifications to ensure that the User Requirements are met and documented in Traceability Matrixes.• Collaborated to support the validation of new metrology equipment introduction to obtain variable measurement data.• Lead a cross-functional team to prioritize/delegate remediation activities, and escalated issues pertaining to the project schedule for resolution.• Facilitated risk-based remediation activities through the application of statistical methods to create, develop, and validate test methods.• Maintained consistent communication with stakeholders on changes in priority, status, and timelines.• Reviewed and approved validation protocols and reports.• Developed and approved robust sampling plans for execution during validation activities.• Remained up-to-date and ensured compliance with current industry trends as well as Quality Systems, ISO13485, cGMP and other relevant regulatory protocols.• Provided support for internal and external audits and Quality System investigations.

St Petersburg, Florida, Us

• Managed relationships with stakeholders while facilitating new equipment inspection and installation activities to deliver work on schedule and budget.• Lead meetings with the core team to prioritize/delegate remediation activities and escalated issues pertaining to the project schedule for resolution.• Collaborated with cross-functional teams to strategically structure change controls to support new process/equipment introduction.• Authored and executed a full suite of validation documentation which included: Validation Plans, User Requirement Specifications, Functional Requirements, Factory Acceptance Test (FAT), GR&R, Installation / Operational / Performance Qualification (IQ/OQ/PQ) and Test Method Validation (TMV) Protocols, Characterization Studies, Summary Reports, and Trace Matrix.• Conducted tests to verify that the specifications were met, and key manufacturing parameters fell within predetermined acceptance criteria tolerances. • Applied statistical methods to create, develop, remediate, and validate test methods.• Facilitated risk-based remediation activities.

Kalamazoo, Mi, Us

• Collected, cleaned, and prepared data from various sources in order to conduct a deep analysis used for data-based decision making.• Served as Data Analyst focused on getting the right data presented in an actionable way to key decision makers allowing them to drive towards business goals and be more effective.• Developed and maintained analytical dashboards with visualizations and reports to track key performance indicators and provide insights to stakeholders.• Benchmarked and tracked process changes against key operational performance indicators.• Created reports, dashboards, and visualizations that effectively communicated data insights to internal stakeholders, including executives, and various cross-functional teams.• Conducted data mining, regression, and quantitative analysis while maintaining data documentation for both internal and external consumption.• Ensured data accuracy, integrity, and compliance with relevant data protection and privacy regulations.• Supported the business through the creation of advanced analytics tools to provide turnkey data solutions.• Developed metrics and conducted analysis for measuring impact of decisions on KPIs• Provided input on design of experiments that appropriately measured impact of process variables.• Conducted analytical research, interpreting results of experiments, and building dashboards.

Kalamazoo, Mi, Us

• Supported the development and introduction of new orthopedic products by working extensively with Product Development, Metrology, Quality, and Operations to take a product from design concept through production ramp up.• Responsible for validating Test Methods (TMV) to ensure quality, reliability, and consistency.• Developed, coordinated, and conducted technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE)• Utilized Minitab to conduct Measurement System Analysis (MSA) or Gauge R&R to assess total %Study Variation• Managed new equipment installation and inspection activities with the metrology team.• Create and release QMS documentation and Preventive Maintenance schedule for multiple equipment including CNC milling, Bead Blast, Laser engraving, Coordinate Measuring Machine (CMM), Robotic Tending, and Furnaces.• Executed equipment validations, process qualification, Measurement System Analysis (MSA) and Gage Repeatability and Reproducibility (GR&R) studies.• Performed dimensional and visual inspection to blueprint guide sheets using CMM, standard gages, customized gauges, and comparators.• Managed suppliers and resolved supplier issues, particularly for Supplier Innovation role.• Participated in multifunctional teams, led by a Project Manager and was responsible for defined project deliverables.• Created documentation in Stryker’s validation system for Master Validation Plan, Process Qualification, Factory Acceptance Test, Site Acceptance Tests, Equipment Qualification, and Measuring System Analysis (GR&R).• Developed process equipment specifications and drafted various SOPs for the operation of new/existing equipment and processes and coordinated training activities accordingly.

• Interfaced with cross-functional internal and external stakeholders on quality related matters. Liaised with contract manufacturing organizations to manage quality control schedules.• Planned, managed and controlled Test Method Validations (TMVs) ensuring that various methods were suitable for intended use.• Execute IQ/OQ/PQ and Test Method Validation (TMV) protocols and characterization studies, summarize data, and write-up report drafts.• Conducted tests to verify that specifications were adhered to and tolerances of key manufacturing parameters fell within predetermined acceptance criteria.• Conducted quantitative root cause analysis to identify corrective and preventative actions, in order to resolve spikes in NCRs and improved the manufacturing process flow.• Planned, identified and performed quantitative risk analysis as needed to facilitate the development and completion of risk file documentation.• Compiled technical data, analyzed key parameters, and drafted technical reports on quality findings. • Participated in FMEA’s and conducted Risk-based decision making in the successful resolution of issues. • Lead technical presentations to communicate quality findings, and project updates to internal stakeholders. • Setup SOPs for technical review and final sign-off's from relevant stakeholders.• Followed change request procedures to modify project scope.• Documented Test Method Validations (TMVs) ensuring that various methods were suitable for intended use.• Verified that specifications are adhered to and tolerances of key manufacturing parameters fell within predetermined acceptance criteria.• prepared document packages for technical review and final sign-off's from relevant signatories.• Executed risk assessments as needed to facilitate the development and completion of risk file documentation

Parsippany, New Jersey, Us

Croll Reynolds Company is an engineering firm specializing in the research, design, and manufacture of process equipment• Developed and managed teams capable of executing performance in adherence of Quality System procedures.• Managed project knowledge and technical documents such as drawings, Production and Process Control Procedures, Inspection Plans, etc.• Planned, managed and monitored communications to ensure that scrubber systems were fabricated in accordance with manufacturing prints.• Developed and planned schedules with defined and sequenced activities based on estimated activity durations.• Planned risk responses such that specifications were adhered to and tolerances of key manufacturing parameters fell within predetermined stakeholder acceptance criteria.• Streamlined design process to increase the right the first-time percentage (RTFT%) Test Method Validations• Liaised with fabrication and component vendors to reduce lead times and meet deadlines.• Consulted with and completed projects for DOW, BASF, Johnson & Johnson, Evonik, PCS Phosphates and more.• Ensured that unit operations and their control systems operate as intended and meet predetermined acceptance criteria.• Revised technical documents such as drawings, work instructions, standard operating procedures, preventive maintenance, and calibration procedures. • Liaised with fabrication and component vendors to facilitate quality initiatives, mitigate risk, and reduce lead times.• Conducted root cause analysis for corrective and preventive actions as they pertain to the design and review of key project deliverables. • Executed design change orders and design reviews with cross functional teams. • Streamlined the design process to increase the right the first time percentage (RTFT %)• Developed new design tools to facilitate and improve data analysis and equipment sizing techniques.• Analyzed complex data for monitoring systems

Syntonic Corporation distributes and installs renewable energy components and turnkey solutions for residential, municipal, and commercial applications. • Conducted system sizing and predictive modeling for PV systems using PVsyst, taking into account shading and pitch effects on projected annual energy production. • Applied value engineering methods on the design of systems by using prewired harnesses, direct bury armored cables, and aluminum wires for cost savings on labor and materials.• Managed two third-party engineering firms to complete drawings for final issue of design deliverables.• Oversaw projects throughout the development phase obtaining various permits from government agencies and utilities.• Liaised with clients, subcontractors, and project managers throughout all phases of the projects. • Provided training to employees and subcontractors in regards to photovoltaic electrical and harness safety via OSHA requirements.

Kingsville, Tx, Us

Texas A&M University Department of Engineering is ranked amongst the top engineering schools in the nation.• Oversaw proper operation and maintenance of pilot scale unit operations including a scrubber, batch enzyme reactor, constant pressure filtration system, heat exchanger, and both tray and packed bed distillation columns• Ensured accuracy of data through calibration of measurement systems such as Nuclear Magnetic Resonance (NMR), Infrared (IR), Gas Chromatography (GC), and PLC Controllers• Increased experiment efficiency by authoring well-defined laboratory experiment procedures• Responsible for assisting in the design of experiments used in the Chemical Engineering undergraduate curriculum. • Implemented pilot scale unit operations and associated PLC control systems such as Liquid Level, Temperature, and Pressure control systems. • Provided safety training, and helped troubleshoot problems for students who were conducting experiments in the lab.• Reviewed and graded lab reports that pertain to scrubbers, PFR reactors, CSTR reactors, rotary kiln driers, and fractional distillation columns.

Corpus Christi Infusion Center is an outpatient facility which provides medium- and long-term infusion services for ambulatory patients.• Utilized basic knowledge of Six Sigma Methodologies to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision making.• Know and follow all laws and policies that apply to distributing medical devices and providing quality care• Prepared weekly and quarterly budget reports mapping the company’s fiscal status and overall progress• Implemented Quality System improvements to meet compliance and overall business goals• Reduced overall cost of antibiotics by 43% by implementing the installation of cleanroom which included a Laminar Airflow Hood (LAH) which met Class 100 (ISO 5) clean bench standards for IV admixture preparation• Conducted medical sampling and testing in accordance with established procedures. • Ensured all lab equipment was properly maintained and calibrated for use. • Analyzed data and provided statistical summaries for documentation of test results. • Filed documentation in accordance with medical compliance initiatives and best standards. • Revised quality system documents and provided training and presentations to other staff members.