Tony Ray Godwin Jr
Quality Assurance Ops Specialist
1125 Garrow Dr. Holly Springs,NC
Summary
Meticulous Biopharmaceutical professional, excellent at juggling multiple tasks and working under pressure. Broad industry experience includes with Quality Assurance, Quality Control, and Manufacturing with the desire of growth to contribute and enhance the pharmaceutical and healthcare industry efficiency.
Overview
10
10
years of professional experience
7
7
years of post-secondary education
Work History
Specialist QA Operation
Beam Therapeutics
Durham, NC
06.2022 - Current
- Maintained database systems to track and analyze operational data.
- Educated staff on organizational mission and goals to help employees achieve success.
- Collected, arranged, and input information into database system.
- Partner with other functional areas for site start-up activities, quality risk management, ongoing continuous improvement and future scale-up as well as for problem resolution.
- Provide QC operations oversight and quality oversight of on the floor activities including plant presence during operations.
- Ensured GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations.
- Assist with product disposition activities of supply produced at the manufacturing facility.
- Real time review of batch records and labels.
- Review and approval of manufacturing discrepancies, laboratory investigations, and change controls.
- Communicated lot disposition pending issues to management.
- Aided in the development and ongoing improvement of applicable quality systems for the site; identifying gaps or improvements, authoring and approval of procedures, and providing training.
- Reviewed and approved validation protocols, calibration and maintenance work orders and asset inductions.
- Provide Quality support towards resolution of material, product, environmental, facility and equipment manufacturing issues.
- Supported functional and facility goals and objectives.
- Responsible for supporting and contributing to quality metrics for the facility.
- Responsible to support and participate in regulatory inspections.
- Responsible for communicating escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or the company brand image to senior management.
Sr QA Engineer
FUJIFILM Diosynth Biotechnologies By Oxford LLC
Holly Springs, NC
10.2024 - 01.2025
- Managed offshore QA resources effectively in order to ensure seamless workflow integration within the team.
- Established key performance indicators for measuring ongoing success of QA initiatives.
- Evaluated new tools and technologies to enhance overall QA effectiveness and accuracy.
- Strengthened collaboration between QA, development, and product management teams through effective communication strategies.
- Utilized advance Quality Software (Kneat GX, Master Control, EIDA) to manage and streamline quality and compliance documents.
- Review and approved validation records, ensuring adherence to regulatory standards and company quality standards.
- Collaborated with CQV teams to address and resolve Deviations and CAPAs, driving continuous improvement in quality processes.
- Earned the Kneat End User Certification, enhancing expertise in digital validation and quality management systems.
Quality Assurance Technical Specialist ARP
FUJIFILM Diosynth Biotechnologies
Morrisville, NC
08.2020 - 04.2022
- Outlined appropriate processes and procedures to fulfill and complete inquiries Increased data-entry productivity by maintaining detailed logs of data projects, identifying issues and improving them.
- Corrected or reported any data entry error to prevent later issues such as duplication or data degradation.
- Verified data integrity and accuracy Batch Record Review.
- Provided regular updates to team leadership on quality metrics, communicating consistency problems or production deficiencies with quality and production leadership.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Gathered data on integration issues and vulnerabilities and reported all findings, including improvement recommendations.
- Prepared QA evaluation reports and submitted to management.
- Batch record review.
- SAP for product release.
- Client interaction
- Project management
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Cross functional teamwork ( Validation, QC, Process Science, Manufacturing)
- Quality Systems Implication.
- Reviewed technical documents and collaborated on customized design to achieve process improvement and compliance.
- Guided staff technology use, assisting with troubleshooting and quality control to streamline operations.
- Documented risk management issues and outlined mitigation actions.
Quality Assurance Technical Specialist ARP
FUJIFILM Diosynth Biotechnologies / Kelly Services
Morrisville, NC
05.2020 - 07.2020
- Gathered data on integration issues and vulnerabilities and reported all findings, including improvement recommendations.
- Prepared QA evaluation reports and submitted to management.
- Batch record review.
- Deviation/CAPA review.
- SAP for product release.
- Client Interaction
- Provided regular updates to team leadership on quality metrics, communicating consistency problems or production deficiencies with quality and production leadership.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Provided analytical, planning and coordination support on projects as assigned, reviewing, interpreting, analyzing and illustrating data to stimulate and support enlightened decision making.
- Quality Systems implication.
- Cross function work (Validation, Process Science, QC, Manufacturing)
- Reviewed technical documents and collaborated on customized design to achieve process improvement and compliance.
- Trained users on desktops, laptops and mobile devices.
- Guided staff technology use, assisting with troubleshooting and quality control to streamline operations.
Quality Assurance Associate III/ Biogen
By Randstad
Durham, NC
08.2019 - 05.2020
- Quality review data and documents for accuracy, clarity, and comparison against standards and/or specifications
- QA on the floor which includes compliance monitoring, deviation assessment/documentation, and investigational support
- Develop understanding of Visual inspection process, inspector qualification.
- Develop understanding of Parenteral clinical and commercial manufacturing process and aseptic practices
- Quality System Implication.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Fixed identified issues to increase productivity and boost workflows.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Monitored product standards and quality-control programs.
- Addressed non-conformance issues, pausing production to correct errors.
- Promoted adherence to quality standards by educating personnel on quality control.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
Quality Raw Materials
Seqirus By Saviance
Holly Springs, NC
02.2019 - 07.2019
- Perform tasks associated with sampling of raw materials, including material transfer, weighing, and sample delivery to labs, following GMP
- Work in controlled environment and follow gowning requirements Inspect materials for foreign debris and document observations
- Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
- LIMS /SAP Material and Sample release
- Track , Deliver, and Receive Materials from Warehouse.
- Monitored inventory to maintain sufficient supply levels to meet business and customer needs.
- Quality System implication.
- Improved resource allocation to promote efficiency and deadline management.
BY FlexForce - Data Entry Coordinator
Biogen
Durham, NC
08.2018 - 01.2019
- Locate data in paper records Transcription of data from paper records into an electronic system
- Verified data integrity and accuracy Batch Record Review
- Analyzed departmental documents for appropriate distribution and filing
- Copied, logged and scanned supporting documentation
- Performed initial client assessment and analysis to begin research process Trouble shoot software issues in an Citrix environment.
- Outlined appropriate processes and procedures to fulfill and complete inquiries
- Increased data-entry productivity by maintaining detailed logs of data projects, identifying issues and improving them
- Corrected or reported any data entry error to prevent later issues such as duplication or data degradation
- Quality system Implication.
- Secured information by completing database backups.
- Compiled and sorted information to prepare source data for computer entry.
- Reviewed, corrected, deleted and re-entered data to eliminate duplication of data and maintain data integrity.
- Maintained data entry requirements by following data program techniques and procedures.
Microbiology Associate
KBI Biopharma By PIPER Company
Durham, NC
12.2017 - 07.2018
- Performs microbiological in-process and release testing in support of GMP manufacturing
- Execute environmental monitoring within all classified manufacturing areas according to approved SOP's and cGMP
- Review EM data for completeness and accurate, and assist with data trending
- Provide EM support for manufacturing during specified dynamic conditions
- Execute water and steam sampling, as well as gas testing, throughout facility
- Perform limited clerical duties, such as data entry and report preparation
- Performed initial client assessment and analysis to begin research process.
- Prioritized tasks to meet tight deadlines, pitching in to assist others with project duties.
- Worked varied hours to meet seasonal and business needs.
O2 Production Tech
MERCK
Durham, NC
10.2017 - 12.2017
- Review GMP records such as logbooks, depyrogenation documentation, sterilization documentation, etc
- Performed Environmental Monitoring, Bioburden, Water Sampling, and Water Filtration Total Organic Carbon
- Performed Aseptic Technique
- Sample and aliquot retention samples and raw materials
- Performed Media Formulation (Lactose, Sauton, Ftm/Tsb, and Youmans)
- Performed gap analysis( SAP, LIMs, Delta-V, PAS-X, CAPA, & Citrix)
- Training personnel of many processes
- Document and report quality and compliance issues to QA management according to required timelines
- Assist in mock regulatory inspections, and regulatory facility inspections
- Verified data integrity and accuracy
- Batch Record Review Trouble Shoot machinery and database
- Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately
- Developed team communications and information for Tier meetings.
Production Tech. 2/ Contractor
Merck/Organon Tek/Agile 1
Durham, NC
02.2015 - 03.2017
- Performed Label and Packaging (Domestic, OSS (international), Canadian, and Vaccine)
- Performed Media Formulation (Lactose, Sauton, Ftm/Tsb, and Youmans)
- Operates manual packaging, fill machines, capping machines, freeze dryers, autoclaves, dry heat ovens, and decontamination in accordance with standard operating procedures
- Maintain concurrent records including manufacturing directions, log sheets, and sanitation practices
- Performs necessary cleaning and disinfecting of equipment and laboratories
- Collects hazardous or non-hazardous waste in correctly labeled barrels or other containers and transfer them to collection areas
- Represent quality assurance and project teams under the direction of more senior QA staff Support management in assessment of compliance to regulations, guidelines and corporate policies
- Trouble Shoot machinery and database
- Analyzed departmental documents for appropriate distribution and filing
- Developed new process for employee evaluation which resulted in marked performance improvements
- Verified data integrity and accuracy
- Batch Record Review
- Implemented systems to improve process efficiency and reduce project duration
- Reduced process downtime by restructuring ongoing projects, ensuring quality and compliance.
Education
Bachelor of Science - Liberal Studies (Race, Class, And Culture)
North Carolina Agricultural & Technical State University
Greensboro, NC 08.2008 - 05.2015
Skills
Materials inspection
Operations monitoring
Risk management processes and analysis
Data management
Safety operation procedures
Manufacturing
Program Capacity Building
Conflict resolution
Experience with diverse populations
Training and Development
Accomplishments
Phi Beta Sigma Fraternity INC.
Prince Hall FreeMason
Duke L.E.A.P. ( Leading Education About Pharmacology)
Bethel AME Mentors Program Greensboro,NC
Timeline
Sr QA Engineer
FUJIFILM Diosynth Biotechnologies By Oxford LLC
10.2024 - 01.2025
Specialist QA Operation
Beam Therapeutics
06.2022 - Current
Quality Assurance Technical Specialist ARP
FUJIFILM Diosynth Biotechnologies
08.2020 - 04.2022
Quality Assurance Technical Specialist ARP
FUJIFILM Diosynth Biotechnologies / Kelly Services
05.2020 - 07.2020
Quality Assurance Associate III/ Biogen
By Randstad
08.2019 - 05.2020
Quality Raw Materials
Seqirus By Saviance
02.2019 - 07.2019
BY FlexForce - Data Entry Coordinator
Biogen
08.2018 - 01.2019
Microbiology Associate
KBI Biopharma By PIPER Company
12.2017 - 07.2018
O2 Production Tech
MERCK
10.2017 - 12.2017
Production Tech. 2/ Contractor
Merck/Organon Tek/Agile 1
02.2015 - 03.2017
Bachelor of Science - Liberal Studies (Race, Class, And Culture)
North Carolina Agricultural & Technical State University
08.2008 - 05.2015