Rochelle S. Black, Pmp, Csm, Sfc Email and Phone Number

Responsible for the oversight and management of end-to-end activities on complex medical diagnostic equipment, assays and business improvement projects utilizing Code of Federal Regulations (21CFR parts 11 & 820) with an emphasis on driving quality execution. Manage Development, Integration, UAT and Launch of Controls Strategy project and wrCRP (C-Reactive Protein) MicroTip project, both with third party suppliers, through Phases 2, 3 and now in Phase 4 & Continuous Improvement; Also successfully progressed Thyroid assays (TT3 II, T3U II) though Phase 1 Closure, into Phase 2. Managed R&D project development team (PMT) for CRP MicroSlide to achieve viable product options during Pre- Phase 0.• Managed PMT Project Team meetings, Project Plans, Schedules, SharePoint Site (RISDA, Phase Deliverables, Trackers, …).• Hosted 3rd Party joint meetings for Controls and wrCRP projects, with agenda / meeting notes, tracking actions and schedule.• Drove wrCRP Project Regulatory Affairs deliverables with tracker to achieve IVDD and prepare for IVDR requirements.• Tracked Thermo MAS Control launch issues raised by Customer Service and Commercial; Manage paths forward to closure.• Additional Tools: BERT Planning/Financials. Windchill/PLM Document Repository, OnePage Project Schedule, DevOps.

Initiate, manage and launch Enterprise Help Desk Integration (HDI) project for Aug 2018 Release. Initiate and manage MPS Oct 2018 Suite Release / Enhancements. Continue managing XIM development of phase 2 Business Intelligence project and Configure Price Quote (CPQ) Operations for monthly releases. Manage cross-functional teams using Xerox Information Management (XIM) Managed Print Services (MPS) Plan Time-To-Market (TTM) Processes with PMBOK and PMP methodologies.• Additional Tools: CA PPM (Clarity), Office Timeline

Managed project initiation thru launch of new Business Intelligence platform for Client Service Performance Reporting. Project adoption rate greater than 90%. Then managed same Business Intelligence - Phase 2 thru development. Managed Onboarding Process for CPO Partners from initiation thru Design Phase. Launched MPS Feb 2016 Suite Release / Enhancements. Manage Configure Price Quote (CPQ) Operations for 2 monthly releases. Led two separate Help Desk Integration (HDI) projects. Manage cross-functional teams using Xerox Information Management (XIM), Managed Print Services (MPS), Plan Time-To-Market (TTM) Processes with PMBOK and PMP methodologies. • Manage resourcing, RACI, planning, coherences, risks, mitigations, project directives, business financials / budgeting.• Initiate / maintain weekly on-line project dashboard, data repositories and action lists.• Chair weekly sponsor reviews, weekly core team and value chain partners meetings. • Execute on required deliverables. Run phase-gate and exception reviews.• Identify and remove barriers to resolve complex IT problems, such as enabling a new BI Platform.• Tools: Microsoft Project, SharePoint, SalesForce, Team Foundation Server, Integrity, OneNote, Business Case Database.

Manage all financial matters and participate in Board of Directors meetings.• Financials include accounts receipts / payables, utilities, payroll and taxes (F941 and 1040 forms).• Manage apartment rental and all facilities repairs. • Negotiate, manage and remit insurance and workmen’s compensation policies. • Process and issue all mail correspondence. • Board of Directors functions include strategy, plans, fundraising and community events.

Manage projects related to Spectrum Infusion pumps with cross-functional teams using Code of Federal Regulations (21 CFR parts 11 & 820). Management includes resourcing, independently plan, execute and provide direction across traditional medical device product lines; all financial aspects of product development including capital expenditures and cross functional expenses. Identify and resolve complex problems. Key areas of focus included• Engineering Research and Development EDPs and KDCs of pump parts with updated drawings & impact assessments.• Manufacturing Processes and Specifications (SOPs) with impact assessments.• Service Processes and Specifications (SOPs) with impact assessments.• Incoming Inspection Processes, Specifications (SOPs) of parts and assembled components with impact assessments.• Interfaced with Human Factors & Usability Engineering activities in design, assembly and maintenance of device parts

This is a bridge assignment while seeking a long term professional position. Substitute Teacher as needed (Math, Science, ELA, General Studies). Also, worked solely alongside Principal to manage all aspects of running this private school, including but not limited to managing website and computers, procuring education and office materials, writing/issuing weekly newsletters, write school articles for publication, photographer, tuition billing/receipts, transportation needs, required health care forms, issuing report cards, fundraising (including raffles, auctions, school store sales, school journal ads,...), school library, support school productions and projects, Math Science Fair judge, manage repairs, upgrades and renovations, ...

Research, develop and manage solution needs for Clinical & Pharmaceutical clienteles and participate in sales opportunities. Deployments include everything from new business processes to custom hardware and software solutions with greater than 90% adoption rates. • Input to new project proposals: define scope, budget and timeline deliverables to clientele. • Lead research and development team in delivering customized solutions per signed contracts. • Manage and recommend upgrades to prior deployments for system upgrades and per client requests and needs.• Weekly participation in business plans, road maps, financial projections and resource forecasting.

Manage development / validation of new packaging components, applied sterilization methodologies and implementation of these treated components with two major product lines of eye care solutions in multiple manufacturing sites for worldwide launch, utilizing Code of Federal Regulations (21 CFR parts 11 & 820) and worldwide Regulatory Affairs. Engaged Human Factors and usability Engineering activities in components and manufacturing.• Product was developed and launched in multiple sizes ahead of designated schedule (less than 8 weeks).• Assembled DDP (Design Development Plan) for program, including Microsoft Project with schedule and resources.• Led team using IOV Matrices, Change Controls, Risk Assessments and CAPA while incorporating Lean methodologies.• Input to Validation Protocols and Quality Assurance for packaging components, batch processing and equipment.• Coordinated Launch Strategy (schedule and expiration dating) with Marketing, Manufacturing & Development.• Managed Design Reviews, Action Items, Team Meetings, Schedules, Documentation and Product Manuals.

Program Manager – Research & Development – Inkjet AiO Printer Writing System, 2007-2008; Manage research and development team responsible for new state of art inkjet writing system that included 13 sub-systems components with integrated technologies and synergies from customer requirements to commercialization to product manuals and marketing. Program was ahead of schedule and under budget at the time the BU terminated it. • Team consisted of 80 senior level engineers, scientists and technicians.• $11M annual first year budget with 3.5-year program schedule utilizing critical path.• Converted ambiguous, complex project / component requirements into measured ones with tolerances.• Created, tracked and documented phases and gates.

Program Manager – Research & Development – IT Interface for Inkjet Systems Division, 2003-2008; Responsible for divisional IT needs, translating them into specifications, providing business justifications and leading integration into corporate IT standards. Total cost savings realized in excess of $7M. • Led DAR, OneLIMs test request / results divisional software tools; converted to corporate standard OneLIMs.• Converted and / or replaced divisional staff computers into TCO corporate standard for cost savings.• Directed lab computers with peripheral supports to support project needs.• Converted and managed electronic file share storage, and utilized TreeSoftPro to address capacity usages.• Co-implemented DOORs software to document controlled project requirements and cost savings.

Program Manager – R & D – Lean Manufacturing / Six Sigma – Inkjet Systems Division, 2002-2004; Responsible for divisional Lean Manufacturing / Six Sigma cost reductions; identified opportunities and executed. Total cost savings realized in excess of $3.5M. • Reduced testing turnaround by 20%; installed new workflow processes improving overall efficiencies.• Created new workflows for environmental testing to minimize chamber condition resets; saved 15%.• Improved consumable material supplies organization and flows to reduce overall inventories by 10%.• Improved method for inventorying printers and peripheral lab equipment to reduce replacements by 10%.• Redesigned pilot operations work flow to improve turnarounds; increased overall efficiencies by 20%.

Program Manager – Research & Development – Universal Sourced Inkjet Media Specialty Products, 2001 - 2002; Directed and delivered universal sourced inkjet media specialty products from global suppliers providing a more diverse product portfolio for sales positioning opportunities and increased revenues. Products were regionally sized and launched world wide. Led new product developments that encompassed research, VOC testing, specifications, business cases. Executed vendor selection, negotiations, quality standards, packaging design / local printer selection. Led logistical product flows through customs, warehousing collection points and distribution centers. Supported sales launch world wide with technical documentation, product manuals, training and scheduling.Program Manager – Research & Development – Universal Cut Sheet Inkjet Media, 1997 – 2001; Responsible for universal cut sheet media, which was required to successfully perform in all competitive printers by equaling or exceeding product features in competitor’s optimized ink / media / printer systems. Five different parent generations of product were launched world wide along with several spin off versions and formats. Led cross functional project teams that increased product line profitability by 15%. Increased customer satisfaction by 10%-15%, resulting in increased revenues. Challenged competition through superior performance and innovation; captured up to 30% of market share. Established process improvement culture and process based on Lean / Six Sigma methodologies. Developed new dies / workflow for perforated sheets and new software to print within the perforated areas.

Project Manager – Research & Development – Graphic Arts, 1996 - 1997; Led cross functional research and development team to convert manufacturing method of producing graphic arts scanner film, which led to a reformulation and installation into a new manufacturing location using process based on Lean / Six Sigma methodologies. Increased product line profitability by 15%.Project Manager - Research & Development – Graphic Arts, 1992 - 1996; Project led multi-international manufacturing site installations of new, state of art graphic arts camera film.Commercialization Engineer - Research & Development – Graphic Arts, 1989 - 1992; Development of new, state of art graphic arts film systems.

Training assignment in R&D to learn how to make photographic emulsions (color paper) and build films (for graphic arts).

Project led interface between product needs and Facilities Engineering to develop and validate process and high speed automated equipment to certify finished Kodak Ektachem blood analyzer testing slides for the potentiometric and colorimetric machines, Clinical Products Division. Also, became Finising Product Engineer. This division was later sold to J&J as Ortho-Clinical & Diagnostics Division.• Developed and launched product utilizing Code of Federal Regulations for Medical Devices (21 CFR parts 11 & 820).• Led team using IOV matrices, Change Controls, Risk Assessments, Validation Protocols, CAPA and Quality Assurance.• Interfaced with Human Factors and Usability Engineering activities in high speed finishing equipment design.• Managed Design Reviews, Project Schedule, Action Items, Team Meetings, Documentation and Product Manuals.

Developed and installed new, updated old, maintained and decommissioned manufacturing equipment and processes in the Film Manufacturing and Plate Division at Kodak Park. Departments included Chemical Preparations, Dispersion Making, Emulsion Making & Finishing and Melting.