Quality Engineer Project Manager
Resume:
Elizabeth-Betty A. Bonsu
Buford GA *****
********@*****.***
CAREER HIGHLIGHT
I am a Professional with experience as a Medical Device Quality Engineer, GMP Validation Engineer and Project Manager. Overall, I have 17 years of experience in the industry.
EDUCATION
National University, La Jolla, CA 2010
MS Engineering Management with Specialization in Project Management
DEVRY UNIVERSITY, Decatur, GA 2007
BS Biomedical Engineering Technology
ACRP, CITI & NIDA- GCP Certified – Renewed 2024.
GMP Training
GLP Certified
PMP Certified
CAREER PROGRESSION:
BioTouch Global Logistics, Distribution, & Supply Chain - Columbus, GA
04/2024- 11/2024
Senior Validation & Quality Engineer - Contract
Develop, execute, and document validation programs for facilities/utilities and equipment.
Assists with the implementation and maintenance of the Quality Management System
Write and execute the supplier qualification process and computer system validation (CSV) validation.
Provide support with the implementation of the Supplier Management Program
Participates in the qualification process of the suppliers.
Assists with the identification of systems requiring validation.
Elevates validation issues appropriately and provides validation expertise.
Contribute to the development, maintenance, and continuous improvement of the Supplier Management
Conduct risk assessments on the Supplier Management process to identify potential risks
Assist with the distribution, follow-up, and evaluation of the supplier questionnaires
Prepares and executes supplier audits according to the created Supplier audit plan
Monitor and trend the outcome of the Supplier audit findings
Assist with the distribution and completion of Supplier Technical Agreements
Assists in the development and revision of procedures (e.g., change control, training, audits)
Assists in the development, execution, and reviews of validation protocols.
Supply appropriate details when requested; and maintains organized files.
Identify potential gaps in the processes and make recommendations for possible improvements.
Stemcell Technology-Vancouver, BC
02/2020- 04/2024
Field Quality Engineer -Medical Devices Quality and Validation (IQOQIPV)
Write, train, and execute all protocol and standard operational procedures for the investigational device.
Write and execute SOP for the installation, and Quality protocol.
Performed IQOQPQ Validation of Facilities, Utilities, Equipment, and Process.
Developed, share validation expertise and scientific understanding of key Pharmaceutical Operations.
Acted as an SME in validation approaches (e.g., Facility, Utility, Equipment, Process)
Acted as an SME in validation activities such as Computer System Validation CFR11.
Perform risk base quality monitoring.
Coordinated and collaborated with cross-functional teams in achieving successful project milestones.
Led all projects customizing project management methodologies to suit the project's specific scope.
Supported projects from product development to technology infrastructure, based on the client needs.
Created and uphold project plans, schedules, and resource tracking mechanisms for assigned projects.
Developed, executed, and documented validation programs for facilities/utilities and equipment.
Developed validation protocols for both internally and for externally manufactured products.
Supported products through Process Design, Process Qualification and Continuous Process Verification
Developed and leads Validation Master plans, in collaboration with manufacturing sites.
Societal CDMO- Gainesville, GA 02/2023- 09/2023
Senior Validation Engineer -Contract
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Developed Standards, Guidelines and SOP to enhance the quality of manufacturing operations.
Performed IQOQPQ Validation of Facilities, Utilities, Equipment, and Process.
Developed, share validation expertise and scientific understanding of key Pharmaceutical Operations.
Acted as an SME in validation approaches (e.g., Facility, Utility, Equipment, Process)
Acted as an SME in validation activities such as Computer System Validation CFR11 approaches.
Coordinated and collaborated with cross-functional teams in achieving successful project milestones.
Led all projects customizing project management methodologies to suit the project's specific scope.
Supported projects from product development to technology infrastructure, based on the client needs.
Created and uphold project plans, schedules, and resource tracking mechanisms for assigned projects.
Developed, executed, and documented validation programs for facilities/utilities and equipment.
Developed validation protocols for both internally and for externally manufactured products.
Supported products through Process Design, Process Qualification and Continuous Process Verification
Developed and leads Validation Master plans, in collaboration with manufacturing sites.
Executed validation projects and ensure that Quality and Regulatory guidelines are enforced.
Executed, provides guidance and oversight and for site validation of facilities/utilities, and equipment.
Developed risk-based approaches to revalidation of products, processes, and systems.
Isensix Inc - Milwaukee, WI
10 / 2017 – 12/2019
Project Management -Engineer -Contract (Monitoring Devices)
Ensured protocol requirements are understood and applied to the design of the lab study.
Ensured adherence to design control procedures.
Collected and analyzed data and apply findings to redesign and improve products.
Developed, tested, and refined prototypes and new product concepts.
Develop Verification/Validation protocols, carry out testing, and write reports.
Install and launch Investigational product at the clinical research sites.
Review all issues found at the site with the research team to resolve.
Write site visit report and upload into electronic database for review.
Perform interim monitoring, auditing, and qualification visit.
Provide continuous monitoring activities (onsite and remote).
Xstrahl Inc - Suwanee, GA 12/2016 – 07/2017
Research and Development Engineer -Contract (Cancer Research Device)
Monitored investigators in a study, to perform clinically relevant radiation research in a preclinical setting.
Monitored and assisted investigators to perform conformal radiation therapy techniques commonly used in clinical practice.
Collected and analyzed data and applied findings to redesign and improve products.
Worked with scientists, medical experts, and clinicians to test and monitor IP at study sites.
Wrote, trained, and executed all protocol and SOP for the investigational device.
Performed site selection, site initiation to access, and ensure the site is ready for the IP before install.
Installed and launched Investigational product at the clinical research sites.
Reviewed all issues found at the sites with the research team to resolve.
Wrote site visit reports and upload into electronic database for review.
Send a follow-up reminder of issue to be resolved to the site.
Performed interim monitoring, auditing, and qualification visit.
Played a pivotal part within the development team, necessitating collaboration.
TEDMED –- Atlanta, GA
11/ 2013 – 11/2016
Independent Contract Senior Clinical Research Associate / Clinical Project Manager
Career Highlight: Independent Contract Senior Clinical Research Associate / Clinical Project Manager. Contract through TedMed with the sponsor, University of North Carolina, HIV study.
Project managed phase I-IV protocols according to the sites monitoring plan and procedures.
Perform onsite and remote PSV, SIV, IMV, Pre-audit, and Booster visit.
Generated PSV, SIV, IMV, Confirmation Letter (CL), Follow-Up-Letter and Closeout (COV) Report.
Oversee development and management of the Audit Plan for clinical programs.
Provided critical leadership and oversight of the clinical quality compliance programs.
Provided lead internal and external clinical compliance programs providing good clinical practice (GCP).
Provided GCP compliance oversight and guidance to multifunctional teams conducting clinical trials.
Supported the clinical vendor management program and the inspection preparedness program.
Oversee TMF audits, investigator site audits, Risk-Based Quality Management.
Represented CRO to ensure successful collaboration, meeting expectation on milestone and deliveries.
Oversee CRA activities in assigned study sites, and networks.
Centers for Dialysis Care 03/ 2013-09/2013
Regional Technical Manager – Contract Project Management
Trained new hires and developed existing employees to promote excellent productivity.
Managed equipment repairs, software upgrade, and preventive maintenance.
Created and managed the departmental budget.
Created and managed the project team schedule to ensure it doesn’t affect budget.
Planned, implemented, and evaluated programs to meet departmental goals.
Mentored, coached, and developed project teams to deliver project service excellence.
Represented clinical engineering in project committees and Council meetings.
Created and implemented new policies and procedure, update OPA knowledge base.
Assisted with developing curriculum and training.
Supervised the Facility Technical Coordinators, FTA’s, FSA, and Float Pool.
Managed all technical operations within CDC defined regions.
Supervised all higher-level water system repairs and upgrades projects deliverables.
Managed the integrity of site inventory and databases.
Directed all aspects of acquisition, maintenance, and repair of equipment.
Ensured all repair activities and order documentation were created according to guidelines.
Managed AAMI inspections and ensured CDC service compliance.
TEDMED LLC –- Atlanta, GA
11/2011 – 02/ 2013
Independent Contract Senior Clinical Research Associate / Clinical Project Manager
Career Highlight: Independent Contract Clinical Research Associate / Clinical Project Manager. Contract through TedMed with the sponsor Abbott, Cardiovascular study.
Developed and oversees study operational plans.
Tasked with managing CRA site assignment decisions to best support project needs.
Perform onsite and remote PSV, SIV, IMV, Pre-audit, and Booster visit.
Generated PSSV, SIV, IMV, Confirmation Letter (CL), Follow-Up-Letter and Closeout (COV) Report.
Provided inputs in the design, planning, and execution of all phases of clinical trials according to GCP standards.
Guided and ensured compliance to ICH GCP guidelines, FDA regulatory requirements, SOPs, and Protocols.
Managed Quality Data System and ensure data completion and accuracy.
Provided guidance to study team in trial SIV, SSV, IMV and close-out activities according to corporate standards.
Reviewed study data and assisted with writing patient outcome narrative.
Visited and oversee initiation, training, and monitoring activities at clinical trial sites.
Provided inputs creating study clinical protocols, study tools, ICF, investigator brochures, and review clinical study reports.
Oversee Clinical Project Managers by leading, training, mentoring, supervising their daily work projects, etc.
Children’s Healthcare of Atlanta - Atlanta, GA
12 / 2008 - 7/2011
Biomedical Technician Clinical Research 2
Performed monthly maintenance, inspection, and repair of various biomedical equipment.
Performed hands-on troubleshooting on various biomedical equipment.
Communicated with customers to provide solutions, and follow-ups on repairs.
Managed delivery processes by vendors, according to company policies.
Documented all repair actions and submitted reports/summaries according to schedule.
Shared on-call / pager responsibility as required.
Maintained an inventory of all medical equipment.
Educated and assisted technicians on simple and intricate repairs.
Ensured proper care of spares, tools and tested equipment and ascertained its calibration.
DaVita Inc. - Decatur, GA
11/2007 - 5/2008
Biomedical Technician 2- Clinical Research
Managed all biomedical dialysis equipment used to collect data on subjects in three research clinics.
Install, repair, qualify, PM and troubleshot all the equipment and record any issue reported.
Prepared reports on service performed in the clinics.
Collected monthly cultures to ensure the water system used to mix the IP for subjects are purified.
Checked on cultures, to identify a need for re-draw.
Responded to on-call pager, for an emergency service request.
Ordered and managed parts for repair and maintenance.
Documented any adverse event involving participants on the device.
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