Marcus Jones
Raleigh,NC
Summary
Quality Assurance professional with strong background in ensuring site integrity and compliance. Skilled in identifying system inefficiencies, implementing effective quality measures, and enhancing operational processes. Known for fostering team collaboration and adapting to evolving project demands while consistently achieving high-quality results. Equipped with analytical skills, attention to detail, and commitment to continuous improvement.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist/Continuous Improvement Manager
KBI Biopharma
06.2021 - 03.2025
- Maintained a master list of all pertinent Supply Chain related projects, issues, and concerns
- Ensured that the Supply Chain team was responsive and executing on meeting strict project specific timelines in conjunction with both the Upstream and Downstream departments
- Authored Raw Material Specific Technical Documents which outlined raw material testing criteria and the required testing methods in alignment with the following: US Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP)
- Subject Matter Expert (SME) of executing monthly audits of facility to ensure strict site Current Good Documentation Practices (cGDP) and Current Good Manufacturing Practices (cGMP) compliance and adherence to site Quality Management Systems 21CFR210 and 21CFR211
- Qualified Trainer and implemented training Modules regarding the monthly QA GMP (Quality Assurance Good Manufacturing Practices) walkthroughs of warehouse areas, raw material sampling areas, and CTU (controlled temperature unit) areas
- Successfully trained six members on the Quality Assurance Raw Materials team on how to properly conduct monthly audits
- Lead Investigator of site-specific Deviation Investigations project in which personnel from different departments collaborated to clear deviation backlog
- Successfully closed 15+ deviations in a timely fashion and implemented CAPA's (Corrective Actions and Preventative Actions) and Effectiveness Checks to ensure that there wouldn't be a repeat in deviations
- Utilized root cause analysis tools 6M method (Manpower, Methods, Machines, Materials, and Mother Diagram), and Ishikawa Diagrams to successfully determine deviation root causes
- Performed audits of manufacturing batch records to ensure Current Good Documentation Practices (cGDP) and Current Good Manufacturing Practices (cGMP)
- Collaborated with the Health, Safety, and Environmental (HSE) department with observing, addressing, and correcting on site safety violations
- Utilized site specific safety application in which 10+ safety observations were submitted to ensure site safety to reduce OSHA (Occupational Safety and Health Administration) recordable observations
- Lead projects pertaining to Raw Material Qualifications: Obtaining and analyzing Material Specifications, in addition to sample paperwork to ensure that Raw Material Qualification standards were being met
- Provided thorough and meticulous review of Controlled Temperature Units (CTU's) logbooks to ensure Current Good Documentation Practice (cGDP) compliance
- Expert technical writer with experience in authoring site specific Standard Operating Procedures (SOP's), Material Qualification documents, Deviation Reports, training documents, Change Control Reports, and CAPA's (Corrective Action and Preventative Action) Reports
- Facilitated an organized environment by implementing the 5S principles (Set, Sort, Standardize, Shine, Sustain)
- Utilized Six Sigma Green Belt certification to lead Continuous Improvement initiatives of Supply Chain and the Warehouse areas
- Utilized Microsoft Visio to organize a process flow chart that detailed the Supply Chain shipping and receiving processes
- Observed for instances of Environmental Monitoring in Aseptic environments
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
Quality Engineer (Contract)
Mindlance Inc; Avantor Fluid Handling LLC
07.2020 - 04.2021
- Led team to address customer issues and Material Review Board (MRB) meetings in an ISO 9001 facility
- Developed spreadsheet tracking system for all incoming materials
- System allowed for identification and tracking of nonconforming materials to address root cause for material defects
- Lead internal audits against Standard Operating Procedural documentation including reconciliation of cleanroom parts between Engineering Process Reports (EPRs) and schematic drawings used in assemblies
- Trained Quality, Warehouse, and Production personnel on these tools
- Trained both warehouse and Quality Assurance personnel on the site-specific inventory system (Epicor)
- Valued member of the safety team including leading risk assessments in the warehouse
- Awarded the Impact Award for properly keeping track of defective assemblies and clean-room parts that were being sent to vendors
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
Quality Engineer/Quality Control Manager
Ideal Fastener Corporation
02.2020 - 03.2020
- Managed the Quality Control team in an ISO 9001 facility; responsible for tracking and addressing production defects; responsible for inspection of both incoming components and outgoing products
- Performed root cause analysis, and Corrective Actions and Preventative Actions (CAPAs) to ensure that the same problems were not duplicated
- Detected for human error, machine error, or both
- Instituted Non-Conforming Material Reports (NCMRs) and wrote SOPs for the facility
- Developed and implemented calibration and audit plans for the lab
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
Senior Technologist
Aerotek
07.2016 - 12.2019
- Was responsible for the testing and formulations of gap fillers and adhesives in an R&D (Research and Development) environment
- Proficient in mechanical testing via Instron, durometer, and micrometer; proficient in viscosity measurements via AR550 and Anton Paar viscometers; proficient in Karl Fischer titrations and thermal conductivity testing
- Instrumental in synthesizing gap fillers while using polyurethanes as a main ingredient
- Led monthly laboratory and site-wide safety audits including proper storage of hazardous chemicals
- Led training initiatives for personnel on various equipment types within the laboratory
- Trained interns on proper use of materials, machinery, and how to navigate working with hazardous materials
- Drove efforts to achieve short-term and long-term business goals by specifying optimal technology solutions for business needs and budget requirements.
- Maintained ongoing education on emerging technologies to discern new, more efficient solutions for ongoing operational needs.
Scientist I- Incoming Quality Associate Specialist
Eurofins Lancaster Laboratories; PSS
04.2017 - 11.2018
- Served as an Associate Specialist in the Incoming Quality department in a GMP regulatory environment at the Organon Teknika site which is a Subsidiary of Merck Pharmaceuticals
- Responsible for accuracy of in-coming paperwork, validation of dimensions of raw materials, tracking incoming products using software solutions
- Utilized instrumentation such as calipers and ANSI (American National Standards Institute) Charts when performing Raw Materials testing
- Safely processed batches containing the Bacillus Calmette-Guérin (BCG) vaccine, including managing cold storage environments and protocols as well as adhering to sampling plan
- Responsible for accuracy of data entered into the site's Global Laboratory Information Management System (GLIMS)
- Implemented Corrective Actions and Preventive Actions (CAPAs) to ensure site safety
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
Quality Control Laboratory Technician
Belcan Technical Services
02.2015 - 07.2016
- Managed the Quality Control Laboratory team and the production chemical operators
- Responsible for SOP documentation, calibration, maintenance and supplies for relevant lab equipment such as pH meters, Gas Chromatograph, Karl Fisher titrator, viscometer, and moisture analyzer
- Utilized Gas Chromatographs (GC) and High-Performance Liquid Chromatography (HPLC) to determine the composition of plastic samples
- Analyzed samples to ensure that qualification standards were met
Education
Bachelor of Science - Polymer And Color Chemistry, Science And Operations Concentration - Textile Engineering, Chemistry And Science Minor in History
North Carolina State University
Raleigh, NC05-2014
Skills
- Detail-oriented
- Quality assurance
- Adept with Warehouse Management Software (ASCTrac, Epicor, and SAP)
- Problem-solving skills
- Analytical thinking
- Internal audits
- Documentation and reporting
- Quality management systems
- Quality improvements
- Customer service
- Team leadership
- Data analysis
Accomplishments
- Supervised team of 15-20 staff members in both Quality Control and Manufacturing environments.
- Led Continuous Improvement initiatives by effectively utilizing both the 5S (Set, Sort, Standardize, Shine, and Sustain) and DMAIC (Define, Measure, Analyze, Improve, Control) principles to ensure site safety and strict adherence to both site SOP's (Standard Operating Procedures) and Quality Management Systems.
- Successfully identified procedural gaps and authored SOP's (Standard Operating Procedures) to ensure procedural linearity and reduce procedural ambiguities.
- Chief internal auditor of start up facility where I was responsible for cross departmental communication and authorization of a site procedure that accurately outlines audit requirements in alignment with Quality Management Systems per FDA (Food and Drug Administration) requirements.
- Qualified Trainer where a team of six personnel were trained on how to conduct audits in accordance to Quality Management System (21CFR210 and 21CFR211) standards.
Hobbies and Interests
- Tutoring
- Reading
- Visual Arts
- Running
- Cycling
- Track and Field
- Lifting Weights
- Caretaking
Certification
- Lean Six Sigma Green Belt
- Lean Six Sigma Black Belt
Languages
English
Native or Bilingual
Interests
- Running- High school and collegiate track and field/cross country athlete; and Half Marathon Runner
- Weightlifting
- Reading
- Caretaking
- Community Service
Timeline
Quality Assurance Specialist/Continuous Improvement Manager
KBI Biopharma
06.2021 - 03.2025
Quality Engineer (Contract)
Mindlance Inc; Avantor Fluid Handling LLC
07.2020 - 04.2021
Quality Engineer/Quality Control Manager
Ideal Fastener Corporation
02.2020 - 03.2020
Scientist I- Incoming Quality Associate Specialist
Eurofins Lancaster Laboratories; PSS
04.2017 - 11.2018
Senior Technologist
Aerotek
07.2016 - 12.2019
Quality Control Laboratory Technician
Belcan Technical Services
02.2015 - 07.2016
Bachelor of Science - Polymer And Color Chemistry, Science And Operations Concentration - Textile Engineering, Chemistry And Science Minor in History
North Carolina State University
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