Quality Assurance Project Management
Resume:
Chibuzo Anojulu
Allentown, PA
Recruiter’s Summary:
Chibuzo is a skilled professional in quality assurance, project management, and documentaƟon within regulated industries such as pharmaceuƟcal and packaging and holds a Bachelor of Science in Neurobiology and has amassed a robust set of technical proficiencies and cerƟficaƟons relevant to GMP, Lean Manufacturing, Six Sigma, and numerous soŌware applicaƟons vital for efficiency and compliance in manufacturing environments.
Spearheaded technology transfer and equipment onboarding iniƟaƟves, significantly enhancing the efficiency and output quality in the Commercial Packaging Area at Sharp Packaging.
She successfully spearheaded the transiƟon of document control systems during a company acquisiƟon, demonstraƟng excepƟonal skills in change management and system integraƟon.
Demonstrated expert proficiency in GMP documentaƟon, quality assurance, and compliance, leading to marked improvements in producƟon methods and equipment performance.
Played a pivotal role in the review and approval workflows of complex documentaƟon within electronic document management systems, ensuring regulatory and industry standards were met.
Implemented cost-saving measures and conƟnuous improvement projects, contribuƟng to substanƟal savings and process opƟmizaƟons for former employers.
Proficient in analyƟcal techniques and problem-solving, directly supporƟng manufacturing operaƟons, and ensuring compliance with SOPs and batch records, improving manufacturing lead Ɵmes and product quality.
Chibuzo is local to Allentown, PA and available to start with 1 week noƟce period. EducaƟon, Achievements & Leadership:
Bachelor of Science in Neurobiology, the Pennsylvania State University December 2018 Presented Research Project at the Society for Developmental Biology Conference IniƟaƟng the poster prep work; UƟlized MS Office tools to create a poster and staƟsƟcal analysis to demonstrate the cell proliferaƟon in the developing chicken lung.
EffecƟvely communicated the work by showing it to Nobel Prize winner. Scholarships: Mary B. White, Rooney Cristo Rey Trustee Scp2, Huck Trustee in Life Science. Summary:
Has over 5 years of experience in managing electronic document management systems (EDMS), overseeing the enƟre document lifecycle from creaƟon to archiving to ensure compliance with regulatory standards.
She is proficient in formaƫng regulatory documents into corporate templates and iniƟaƟng workflows within EDMS for risk management, ensuring alignment with safety policies, quality systems, and cGMP requirements.
Chibuzo has a strong background in ediƟng quality documents, such as SOPs and guidelines, to ensure they meet regulatory requirements, and manages and reviews batch records to maintain compliance.
She successfully spearheaded the transiƟon of document control systems during a company acquisiƟon, demonstraƟng excepƟonal skills in change management and system integraƟon.
Professional Project management with 2+ years in operaƟons.
Review System Development Life Cycle (SDLC) documenta on invesƟgaƟons and change controls.
Good Knowledge of EDMS, Veeva, SharePoint, excel, Plans and Risk EvaluaƟon on and
MigraƟon Strategy (REMS), document review and approval, and word.
Manages the review and approval workflows and performs other document control-related archives with the EDMS as assigned.
Formaƫng regulatory documents into the corporaƟon’s core template, iniƟaƟng workflows in the Electronic Document Management System (EDMS) for risk management.
3 Years of word process skills.
Worked with process development groups, program managers, knowledge management, and IT experts to develop and advance organizaƟonal capabiliƟes and program knowledge structure and flow.
Responsible for technical wriƟng/ediƟng and Proofreading for all types of documentaƟon produced within a modern so ware development environment.
Served as Point of Contact for acquired company’s transiƟon to all Merck systems and processes.
Implemented and documented computer program changes, reviewed computer system documents, provided feedback to meet regulatory and industry expectaƟons.
Demonstrated skills in using the computer to access informaƟon, perform job funcƟons (e.g., spreadsheets, PowerPoint), prepared other reports, and good working knowledge of MicrosoŌ
Excel and Word. Interact with clients to build relaƟonships to anƟcipate, meet, and exceed client expectaƟons. Technical Proficiencies:
GMP: Batch records, Standard OperaƟng Procedures (SOPs), GMP DocumentaƟon, QA/QC, Data Review, cGMP, SOP, InvesƟgaƟons, Manufacturing, packaging, logbooks, Excel spreadsheet, second person review, building exit checklist, creaƟng a job descripƟon, e-shop floor, LIMS, COMET & SAP, PharmaceuƟcs, CAPA, Change management, Technical WriƟng, and GxP, GMP
(Good Manufacturing PracƟces), {also cGMP} eQRMS, EDOC, MBRs, MES, QTS, QMS, Root cause analysis, and inventory management system, RFT, and non-conformance. Project Management: Leadership, Problem Solving, Interpersonal Skills, CriƟcal Thinking, Teamwork, Outlook, Time Management, Cisco WebEx, Excel ManipulaƟon, Risk Management, lean, MPS, A3, Kanban, Agile, and PMP cerƟficate, PMBOK, and criƟcal thinking skills, communicaƟon skills, aand interpersonal skills.
ScienƟfic: 3D reconstrucƟon, Cell Culture, RecrystallizaƟon of Acetanilide, simple and fracƟonal disƟllaƟon, staining, and washing embryonic chick lung. SoŌware: MicrosoŌ Excel, Word, Word processing, PowerPoint, MicrosoŌ outlook, Adobe sign, Exostar, ImageJ, MATLAB, LIMS, ELN, MS Teams, Veeva, MIDAS, SharePoint, Track wise, NauƟlus, synacde, eTraige, sharepoint, and eQRMS .
SoŌ Skills: CriƟcal Thinking, teamwork, training, management, leadership, public speaking, detail orientated, and cross-funcƟonal project teams.
Professional Experience:
Sharp Packaging December 2022-Jan 2024
Quality Control Specialist/Line Lead
Will be assigned to a line/area as a producƟon person; (usually the supply person).
Communicates supervisor’s job orders to employees.
Get machines started efficiently.
Call a mechanic when the machine is down.
Recheck components brought onto the line by the material handler against the batch record.
Call a material handler to restock the line.
Check quality, LOT number and expiraƟon date while the job is running.
Ensure 200 % inspecƟon forms are completed, as required.
Ensure all batch recorded entries, including daily room checks, are performed.
Assist with lot changes by counƟng components for accurate accountability.
Calculate and record counts as required.
Maintain line/area in an orderly and safe manner while maintaining GMPs.
NoƟfy supervisor if personnel issues arise.
Report down me on appropriate form.
Observe packaging operaƟons for op mum performance.
Recommend measures to improve procedure on methods, equipment performance, and quality of product.
Assist supervisor with reporƟng the producƟon performance metrics.
Suggest changes in working condiƟons and use of equipment to increase efficiency of work crew. Sanofi February 2020-August 2022
Quality Assurance Shopfloor Specialist/DocumentaƟon management
Perform real Ɵme review of manufacturing and batch records.
Provides direct shop floor quality support to ensure manufacturing acƟviƟes are performed in compliance with effecƟve SOP&SWI
Review manufacturing shop floor documentaƟon.
Area/Line clearance.
Manages the review and approval workflows and performs other document control-related acƟviƟes with the EDMS as assigned.
Review System Development Life Cycle (SDLC) documentaƟon, invesƟgaƟons and change controls.
Help manage and direct manufacturing operaƟons, manufacturing leads, Quality assurance leads, while watching 20 processes while on the floor.
DeviaƟons support-risk assessments and closures.
Provide guidance to resolve compliance issues and procedural errors in real Ɵme.
Review documentaƟon- logbooks, SRNs, Daily Releases, Batch records.
First responder to address any non-rouƟne events on shop floor.
Ensure manufacturing compliance with applicable procedures and batch records.
Issue producƟon batch records and product labels to OperaƟons.
Strong authorship and ability to criƟcally review invesƟgaƟons, interpret results and generate technical conclusions consistent with Quality risk management principles.
Build and maintain relaƟonships with Manufacturing OperaƟons, Quality Control, Manufacturing Science& Technology and other departments of effecƟvely accomplish responsibiliƟes make improvements and resolve issues.
Contribute to the compleƟon of complex projects, manage own Ɵme to meet agreed targets and. Develop plans for work acƟviƟes on own projects within a team.
Skilled in planning and organizing, decision-making, and building relaƟonships.
ParƟcipate in Limited DuraƟon Teams, Right First Time (RFT) Improvement projects, correcƟve acƟon/ preventaƟve acƟon effecƟveness.
Knowledge of quality processes, including material disposiƟon, change control, product complaints, deviaƟons, invesƟgaƟons and CAPA management.
Able to work in the cleanroom environment for 6-hour Ɵme periods.
Assist and support project team with data verificaƟon.
Make Quality decision to resolve moderately complex issues with assistance from management.
Help to define appropriate acƟon plans for improvement and follow-up and communicate acƟon closures.
Sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operaƟons and processes.
Directed quality iniƟaƟves that accomplish conƟnuous improvement and enhance site quality system efficiencies.
AcƟon-oriented and customer-focused and skilled in decision-making, building relaƟonships, problem solving, conflict management, planning and organizing, resource allocaƟon, coaching others, and analyƟcal thinking.
Possess an independent mindset.
Review study specific regulatory binders and documents to ensure all documents are appropriately completed, submiƩed, and maintained per GCP standard.
Requires moderate direcƟon to complete more complex tasks; completes rouƟne task with liƩle or no supervision.
ProacƟvely work with team members to ensure the Ɵmely compleƟon of correcƟve and preventaƟve acƟons to avoid recurrence of deviaƟons.
Perform task in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Experiences with asepƟc processing in ISO 5 clean room and or biosafety cabinets.
Familiarity with COMET SAP, SAP Business, MES, Trackwise, or equivalent systems.
Review and support in the compleƟon of rouƟne CAR-T manufacturing invesƟgaƟons.
PracƟcal knowledge in current Good Manufacturing PracƟces.
Confident in making decisions for non-rouƟne issues.
AsepƟc Process SimulaƟons / IntervenƟons ObservaƟons.
Real review of all documentaƟon and reporƟng in support of process unit operaƟons.
Provide QA shop floor support for extended periods of Ɵme.
RouƟnely recognizes and resolves Quality issues; informs management of proposed soluƟons. Seeks management guidance on complex issues.
Proposes soluƟons for complex issues and works with management to resolve. Follows & develops established procedures and performs work as assigned.
Technical knowledge of operators and shop floor managers by providing posiƟve and construcƟve feedback. Merck Sumneytown PA February 2019-March 2020
Senior Project Specialist (Vaccine Process Development & CommercializaƟon), Business Systems
Built transformaƟonal and lean capabiliƟes for the centralizaƟon and standardizaƟon of business pracƟces and systems (Tier, communicaƟon, templates, etc.).
Developed tools, templates, and schedules as necessary for recurring tasks to improve team producƟvity.
Worked with process development groups, program managers, knowledge management, and IT experts to develop and advance organizaƟonal capabiliƟes and program knowledge structure and flow.
Supported the development and execuƟon of business systems that support group needs
Provided guidance on compliance/GMP requirements and departmental systems (training and documentaƟon) and idenƟfy and implement iniƟaƟves to strengthen the VPDC GXP Compliance posiƟon in collaboraƟon with Quality organizaƟon and L&D group
Provided mentorship and systems direcƟon to other team members, which may include doƩed-line reporƟng relaƟonships.
Oversaw and coordinated work performed by contractors.
Used a MicrosoŌ Excel spreadsheet to create a terminaƟon checklist for people managers (Ɵer 2).
Used one note to present informaƟon on building compliance in VPDC (Vaccine Process Development & CommercializaƟon).
Wrote BP (Business procedure), LP (Lab procedure), and SOP.
OrganizaƟon document control room and preparaƟon of completed Batch Records documents retransfers QA Document.
Helped with migraƟon of IT informaƟon.
Provided direct shop floor quality to ensure manufacturing acƟviƟes are performed in compliance with SOPs.
Increased the quality and compliance culture in manufacturing areas.
Created VPDC Research Plaƞorm for FuncƟonal Managers in Word.
Second Person Review Documents needed for producƟon release.
SPR (Second Person Review) training for new employees.
Updated Vaccine Process Development & CommercializaƟon Share-Point/Wiki Page.
Designed, developed, and updated required technical documentaƟon.
Responsible for technical wriƟng/ediƟng for all types of documentaƟon produced within a modern soŌware development environment.
UƟlized knowledge of word processing soŌware, strong wriƟng, and analyƟcal skills.
Tracked and reviewed change control documentaƟon.
Assisted with the ediƟng of quality documents (SOP's, guidelines, InstrucƟons, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high degree of accuracy.
Possessed sound interpersonal and informaƟon gathering skills, be able to relate well to others at all levels throughout the organizaƟon and can work in a team environment, effecƟvely interacƟng with others.
Reviewed current documents, incorporaƟng comments from project leaders and other SMEs.
Navigated through Electronic Document Management System (EDMS) uƟlized current templates.
NoƟfied project leaders or SME of workflow status and issues.
Incorporated comments from team members and provide status to project leader on review and approval workflow.
UƟlized Excel as a DocumentaƟon / CommunicaƟon Tracker.
Product supply chain/ clinical supply chain.
Eurofins, Lancaster PA August 2018-December 2018
Quality Assurance/Data Review ScienƟst (Biochemistry)
It was ensured that the client received quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and GLP regulaƟons.
Reviewed and performed approval of GMP documents such as SOP's and batch records for the Biochemistry department.
Provided informaƟon and revision support for updaƟng company publicaƟons, including quality policy manuals, company web site, and newsleƩers.
IdenƟfied and drove system improvements, both within the department and for laboratory operaƟons; determine the most effecƟve way to accomplish a goal or strategy; suggest improvements to maximize quality and producƟvity.
Reviewed QC data and non-conformance issues for assigned technical groups, evaluate for trends or paƩerns.
InvesƟgated and documented QA, method, and regulatory deficiencies within the lab; escalaƟon when needed; diagnose and solve problems independently.
Implemented and documented computer program changes, reviewed computer system documents, provide feedback to meet regulatory and industry expectaƟons.
Worked efficiently, documented work clearly, and performed duƟes accurately
Applied GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriate.
Reviewed client or agency documents, idenƟfied requirements outside our usual pracƟces, communicated to technical operaƟons, and assisted with implemenƟng appropriate changes.
Kept abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authoriƟes regarding any special QA requirements they may have, assist technical operaƟons with applicaƟon and interpretaƟons.
Learned new techniques, perform mulƟple tasks simultaneously, keep accurate records, follow instrucƟons, and comply with company policies.
Performed internal quality assurance audits.
Demonstrated skills in using the computer to access informaƟon, perform job funcƟons (e.g., spreadsheets, PowerPoint), and prepared other reports.
Data reviewed (analyƟcal, validaƟon, invesƟgaƟons), checked for compliance, idenƟfied issues, and provide opƟons for resoluƟon.
Supported manufacturing services through the review and approval of master batch records and completed manufacturing records for review, and release of the manufactured product.
Documented control through management, issuance, authoring, and approval of documents (SOPs, Monographs, InvesƟgaƟons).
Management of equipment in the QA databases. Interact with clients to build relaƟonships to anƟcipate, meet, and exceed client expectaƟons.
RegulaƟons pertaining to subject 21 CFR.
Sharp, Allentown PA January 2017-August 2017
DocumentaƟon Coordinator
Supported manufacturing services through the review and approval of master batch records and completed manufacturing records for review, and release of the manufactured product.
Documented control through management, issuance, authoring, and approval of documents (SOPs, Monographs, InvesƟgaƟons).
Management of equipment in the QA databases. Interact with clients to build relaƟonships to anƟcipate, meet, and exceed client expectaƟons.
Princeton University, NJ Summers 2011 -2016
Princeton Research Intern
Monitored high school students to develop the skills needed when extracƟng embryonic chicken lung.
Selected as a sophomore to parƟcipate in the Society for Developmental Biology's Choose Development program, funded by NaƟonal Science.
FoundaƟon—pairs undergrad students across the United States with leading researchers in developmental biology for professional development and long-term research projects.
Spent three consecuƟve summers quanƟfying paƩerns of cellular proliferaƟon during monopodial branching in the developing chicken lung.
Captured image stacks using spinning disk confocal and image J. Image slices of the embryonic lung were taken then each slice was then taken to ImageJ to count the proliferaƟng cell in the mesenchyme and epithelial layer of the lung.
Research work was demonstrated on Penn State today newsleƩer & Lehigh Valley News. Project Management Experience
Lead group projects – IniƟated and presented a group project by explaining the effects of epilepsy in children as a final project for the integraƟve Neuroscience class.
Board Council work - Communicated with Board members of the Allentown School District to improve student learning and connecƟons to the community. Students where they helped to take classes which focused on improving resumes.
DocumentaƟon Coordinator Sharp - Supported manufacturing services through the review and approval of master batch records completed manufacturing records for review, approval, and manufactured product release. Document control through management, issuance, authoring, and approval of documents (SOPs, Monographs, InvesƟgaƟons). Management of equipment in the QA databases. Interact with clients to build relaƟonships to anƟcipate, meet, and exceed client expectaƟons.
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