Post Job Free

Resume

Sign in

Project Management Quality Assurance

Location:
Nairobi, Nairobi County, Kenya
Posted:
December 28, 2023

Contact this candidate

Resume:

JACK MILLONDE

Newark, DE *****

+1-610-***-****

+254-***-***-***

ad1917@r.postjobfree.com

SUMMARY:

Accomplished professional with vast experience in Project Management, Healthcare Information systems, Supplier Management, Healthcare Production and equipment management, Healthcare Manufacturing, Communication, Product Launch and Relationship Management, Training, Education and ICT Industries. A remarkable expertise in Operations Management, with a passion for Customer Relations Management with demonstrable problem-solving capabilities.

SKILLS AND COMPETENCES

Project Management

Relationship management

Healthcare Management

Healthcare Product Labeling

Training and Communication

Account Management

Hiring & Mentoring

Learning Management System (LMS)

Risk Assessment

Quality Assurance

Change Management

Problem solving

Marketing Communication

Oracle Modules & Operations

Collegiate Management

Planning & Coordination

Project management tools,

Microsoft teams, Teamwork, Jira, MS Office, WebEx, Vidyo, Cornerstone, People soft, Oracle, and all the video conferencing tools necessary. Agile. Ensur, Fourth Shift,

PROFESSIONAL EXPERIENCE

Quality Labeling Design Change Specialist

March 2022 - Present

Abbott Labs Diagnostics, USA,

Duties and Responsibilities

Build Project management tracker to manage labeling interdependency projects (LIPs).

Coordinate the labeling process with external parties and manage third party labeling in the electronic

document control systems.

Manage SharePoint /Teams site for stakeholders Design Change and Design Control Execution.

Track timeliness, risks to ensure material purchasing and production build time for ID NOW Covid 2.0, Strep, RSV, Flu assays,test swabs and medical equipment have up-to-date labeling for shipping to the various warehouses and countries specific.

Facilitate IVDR, IVDD assay and equipment design Control project delivery from initiation to Implementation launch.

Responsible for ensuring that product changes are implemented into the QMS, in conjunction with project leads.

Meet and communicate with vendors to ensure quality of products are met

Review Statement of work (SOW) in accordance with Service requisition and align with departmental budget and approvals

Ensure Material quarantine procedures are followed during labeling implementation.

Prepare Labeling change request (LCR) documents Design Change Process Improvement to reduce CAPA and Quality incidents:

Manage any Molecular Covid and lateral Flow labeling related projects and facilitate successful manufacturing.

Initiate and manage Cross functional approval through collaboration to ensure timely approvals that are deadline compliant.

Assist in the constant improvement of SOPs to align with standard operational procedures.

Collaborate with external vendors Global Strategic Marketing (GSM) and Acolad to affirm artwork and Translations.

Attend to critical Change actions driven by Change requests (CR) and Change Orders (CO)

Work with the project leads From Engineering, Marketing, Research and Development, Supplier Quality, IT, Regulatory, Corporate, Quality Assurance and Countries to manage successful Implementation of First -lot to Stock (FLTS).

Control process including timelines, meeting scheduling, meeting minutes,

assigning deliverables and actions, and essential paperwork.

Assist R&D and project managers with coordination and planning for new product and change implementation

Communicate project status to management team and internal and external

Stakeholders and Provide metrics for the change control process.

Compile and maintain all quality system records and Documentation

associated with design change projects, including project definitions, first-lot-to-stock,

product qualification records, etc. Ensure records for design change projects

and align with standard operating procedures.

Manage organization, storage, and archival of Labeling Process with internal and external

Utilize Quality System Support Provide training on the design control process and the label review

and approval process..

Participate in supplier post-market evaluations of new products or changed products

Ensure compliance to U.S.(FDA) and international regulations (NB) requirements.

Direct customer inquiry and complaint to appropriate resolution units for responses.

Manage Safety Data Sheet creation and revisions for Abbott Diagnostics Scarborough, Inc. products

Project Manager

December 2019 – March 2022

Siemens Healthcare Diagnostics, DE USA,

Duties and Responsibilities

Manage and oversee the Assay Clinical Chemistry Labeling department projects and Implementation priorities.

Manages In Vitro Diagnostic regulations (IVDR) review process including assembling and routing review forms and labeling, scheduling and running review meetings, and consolidating review feedback.

Manages design change process from initiation to completion in line with Company and departmental quality Plan

Manages workload to meet committed dates and escalated workload concerns as needed.

Conduct weekly sprint meetings and escalate priorities and risks

Escalates questions to internal team and participates in team meetings as needed.

work across product lines, with the internal team including technical leaders, content developers, and proofreaders and with external cross-function

Collaborate cross functional teams to ensure all stages of the product life cycle are followed for successful implementation.

Compile technical review documentation and ensure all required technical reviewers are present for review and approvals.

Utilize Microsoft project tools to track project progress, Scheduling, and resource management.

Provide Relationship representation for

Ensure all project procedures are aligned with company regulatory procedures internationally

Ensure that Design control department authenticates siemens assay and diagnostic equipment implementation.

Coordinate with manufacturing department to ensure all labels conform with the ISO standards.

Communicate constantly with the different site and product leads to ensure a harmonized implementation schedule is realized.

Communicate any medical diagnostic, point of care procedural changes to the team and provide timelines for completion.

June 2019 - Dec 2019

Program Coordinator - School District of Philadelphia

Job Summary

Oversees the implementation of the programmatic activities at various school sites or the Partnerships in Character Education and the Learn and Serve Youth Driven Service-Learning grants, Early Childhood Regional Center, Facilities Management Services. Procurement Services or in High Schools. Oversees the program operations and assures that the programmatic operations are in compliance with the grant or operating budget for the assigned area.

Duties and Responsibilities

Directs and oversees all program components and ensures that staff is adequately trained in their functions; establishes program goals to ensure that needed services are provided; ensures that all program personnel are working in collaboration with one another.

Works closely with personnel external to the School District to ensure the coordinated delivery of high-quality services by community-based agencies in partnership with the School District or contractors working with District K-8 teachers representing various District regions and multiple schools.

Assists with the collection of data and evaluation of the program's effectiveness; works with Information Technology to compile reports and statistics; assists with the analysis of service delivery and student progress; disseminates the information to regional offices and schools.

Works with clientele from the Regional Talent Center.

Oversees program implementation in the assigned high school; represents the school at program meetings with various community organizations; participates in the implementation of program strategies to facilitate the achievement of programmatic objectives.

Oversees the design and maintenance of a comprehensive record keeping system related to the utilization of the site network.

Maintains liaison with school administrators and staff.

Directs and oversees components of the financial and administrative operations within Facilities Management Services.

Manage and Coordinate Utilities verification project for all District school. Communicate, address and validate, PECO, Gas, PWD water, Heating oil meters and billing to ensure accuracy and efficiency. Work with Evolution energy consulting firms to maintain accurate utility data and readings.

Assist and coordinate with Goby ERP, Oracle ERP implementation for School district of Philadelphia

Ensures that staff is adequately trained to perform their duties.

Establishes goals to ensure that financial and administrative functions are performed efficiently.

Ensures that department personnel are working in collaboration with one another.

Oversees quality assurance and compliance for financial and administrative operations, to include reviews of work orders, utility accounts, financial transfers, employee reimbursement, accounts payable/receivable, and collections for reimbursements for services provided by Facilities Management Services.

Assists with the collection of data and evaluation of Facilities Management Services department effectiveness; works with members of the CMMS implementation team to help organize and

compile performance reports.

Troubleshoots any issues between the School District of Philadelphia and contracted vendor

Works with souring units to ensure contracts are in place without any time lapse.

Performs contract pricing and quality audits to ensure the suppliers are in compliance with the contract.

Engages with client schools and departments to ensure suppliers are performing satisfactory work.

July 2018 - June 2019

Project Coordinator EHR (Electronic Health Record) Implementation

Resource for Human Development - Philadelphia, USA

Duties and Responsibilities

Responsible for coordinating and supporting all new and existing projects related to the EHR by following all the SDLC (Software development life cycle).

Lead point person between the Project Manager, Clinical Director, Revenue Cycle and related technology units throughout the implementation process.

Maintain and oversee patch management schedule within UAT, Development and Live environment by Navigating Netsmart Portal for Patch and release updates.

Generate project plan for the project team in collaboration with the Project Manager and in alignment with client schedules.

Log all new projects for status, and review update meetings for Management and stakeholders.

Schedule and attend daily sprint meetings, weekly planning and update meetings in guide with the agile and Scrum methodologies.

Update new task in the project management tools like Teamwork, Microsoft teams and use of MS project.

Plan deployment meetings, ensure new product specs are written to specification for deploy

Ensure QA approves new forms and report request.

Ensure all patches are current in the different environments like the UAT, before Go Live and post Go Live.

Work with Training and Organizational Development to ensure adequate training of the system is rendered before go live roll out.

Manage the Report and forms database status.

Track project progress and report any delays to the relevant owners for vital action.

Plan and attend readiness engagements with clients and stakeholders in the corporate office.

February 2018 - May 2018

Project Lead Analyst

CITI GROUP DELAWARE, USA

Duties and Responsibilities

Responsible for the FACTA and CRS due diligence preparation and analysis.

Conduct pre evaluation to ensure clients and entities follow the IRS tax rules and have valid documentations. Comply with AML regulations to in accordance to Citigroup corporate rules and regulations.

Navigate Tax portal for upload of W8 and W9 tax forms. Utilize Validation tools GPHRS, IPS, CRS validation tool to validate Clients tax forms. Ensure that client account details are a match in KYC, eTACS and AMC. Research internal systems to ensure formation documents are up to date authenticated. Ensure Exemption rules reportable and non-reportable clients are communicated and adhered to. Develops reporting and control procedures, preparation of information required for financial reporting and analysis and professional usage of share point.

Translate the Business requirement document and work tech team to implement both functional requirements.

Liaise with Other project departments to ensure project activities and delivery is seamless. Supports business activities by providing advice on financial implications related to business trends and products,

Highlight risks associated with project deliverables and provide way forward to the gaps identified through elaborate communication.

Responsibilities encompass all tax-related activities, including tax planning, tax filing and compliance and other tax reporting including preparation of tax reports for both tax returns and support of tax reporting systems.

Conduct Learning and development through training to global clients on policy and compliance of the project initiatives and requirements.

Provide relationship management, Customer service, Professional Communication to global and local clients and respond to inquiries on time with appropriate solutions to the queries.

Ensure project deliverables and milestones are signed off on time with minimal constraints without compromising quality.

Use JIRA to track project progress and evaluate feedback to better business practices.

August 2013 - April 2017

Project Relationship and Account Operations Manager

August 2013 - April 2017

DHANUSH INFOTECH USA, TN

Project Location- Nairobi, Kenya

Duties and Responsibilities

Hire, train and manage Commutation staff responsible for Project call center at the National Treasury & Planning (Ministry of Finance) of the Republic of Kenya.

Ensure there is a call support matrix that addresses all queries raised in the meetings and project as a whole.

Provide solutions arising from summarized communication, call center and client feedbacks.

Collect business requirement on the BRD and work with cross functional teams to ensure all stages of the product life cycle are followed for successful implementation.

Utilize Microsoft project tools to track project progress, Scheduling, and resource management.

Provide Relationship representation for FMIS Academy capacity building contract and services between Government of Kenya ministries, Counties, Departments Parastatals, agencies and other project partners and stake holders.

Liaise with Oracle office to ensure the training curriculum, program, and resource hiring is compliant with oracle standards.

Provide Leadership to the project team during deliverables and liaise with Country CEO to ensure adequate operation strategies for project deliveries from project initiation to project closure.

Attend all high profile meetings with project donors and project partners to ensure compliance is adhered to and quality assurance is not compromised.

Present weekly, monthly and quarterly reports to the board Members on progress, status and highlighting risk components.

Implement monitoring and evaluation mechanisms through efficient feedback methodology that helps align project delivery and improve effectiveness.

Convene weekly Skype meetings with offshore teams and onsite team members to deliberate on the project status, challenges and mitigation measures.

Generate retention programs and ensure that all operations are galvanized by team success and team rewards through quarterly team change management workshops and team building initiatives offsite.

Manage and supervise diverse staff by hiring, assigning duties and tasks, Evaluate resources and review of project delivery through SMART HR system.

Utilize agile methodology in project management methodology to execute projects.

June 2011 - August 2013

Training Coordinator/Administrator

DHANUSH INFOTECH TN USA,

Project Location- Nairobi, Kenya

Duties and Responsibilities

Maintained up to date and Standard Trainer Curriculums.

Coordinate daily training and administrative operations at Kenya school of Government, Lower Kabete campus for IFMIS Academy.

Responsible for maintaining trainee’s record data base.

Conduct training need assessment online using open source tools and field survey.

Ensure accounting and payment of services and goods are done on a timely manner with accounts and finance department

Upload and approve LMS contents to ensure quality using the administrative dashboard

Liaise with trainers to ensure training curriculums are all up to standard and up to date.

Update training content on Cloud for effective storage and safe access

Oversee procurement of goods, manage vendor contracts and maintain constant inventories, arrange for daily outsourced transport for both staff and participants as needed authorize use of motor vehicles for dignitaries and client’s visits.

Ensure that training of Government officials is classified, and protocol observed when attending to the various classes of officers and highly regarded dignitaries and personnel.

Generate and manage a yearly training calendar that includes and cover training of Senior Government Procurement officers, budget officers, Auditors, HR, Finance officers and ICT officers.

JUNE 2010– June 2011

Manager-Sports Equipment Procurement and Supply chain

SAINT JOSEPH'S UNIVERSITY, PENNSYLVANIA, USA

Duties and Responsibilities

Headed the University Change and Implementation Management Committee (CHIMAC).

Guide, train and prepare department employees on projects and compliance.

Interface with the various departments and lay solve budgetary needs.

Manage all Nike, Adidas, and multiple sports vendors from bid to award of the tender and through distribution.

Maintain and manage the University training facility and operations.

Develop and maintain electronic tracking system with our IT department to ease audit and inventory stock taking.

Liaise with stakeholders to ensure procurement regulations are not breached.

Regulate stadium contracts and ensure efficiency in vehicle and machine procurement. Head of University (CHIMAC) Change and implementation management committee.

Enhanced Marketing Communication through TV and Media Houses.

June 2003-2010

Manager Ticket Sales and Marketing Operations

SAINT JOSEPH'S UNIVERSITY, PENNSYLVANIA, USA

Develop and implements retaining programs for corporate sponsors and Donors.

Hire, train and conduct orientation for employees and volunteers.

Initiate and unveil marketing projects for employees and volunteers.

Manage and maintain financial accounting deposits for the department.

JUNE 2003 – 2007

BRANDYWINE SUITES (CHOICE HOTELs)-

WILMINGTON, DELAWARE USA

Duties and Responsibilities

Customer Relations Supervisor

Always strove to Maintain High guest Quality and Satisfaction .

Improved employee employer’s Relations through Audits & Surveys.

Represent corporate and management in annual conferences local and internationally.

Manage the hotel call center for guest services

Hire, train and conduct orientation for new teams.

Monitor and evaluate guest complaints during and after stay through online interactive software.

Maintain guest quality and satisfaction during and after stay.

Liaison between corporate office and the franchise hotel.

ACADEMIC AND PROFESSIONAL ATTAINMENT

May 2010

Master of Science -Organizational Development and Leadership (Major in Leadership & Change)

SAINT JOSEPH’S UNIVERSITY, PHILADELPHIA PA 19131, USA.

May 2003

Bachelor of Science - Business Administration (Major in Marketing & Management)

LONG ISLAND UNIVERSITY, NEW YORK, USA

Certification:

Scrum Master Certification (in progress) Course Alliance

Scrum Fundamentals Certified

Six Sigma Yellow belt

PMP Training certificate (Computer Pride College Nairobi, Kenya) July 2015

Management Training certificate (Saint Joseph’s University, Philadelphia Pa 19131) 2010

Computer Proficiency

Proficiency in using the Microsoft Office Suite

experience with project management tools.



Contact this candidate