Open To Work
Crystal James-Owens III
Lansing,IL
Summary
Possess versatile skills in project management, problem-solving, and collaboration. Strong commitment to quality and success. Recognized for adaptability and proactive approach in delivering effective solutions. Considerable experience in Quality Control/Quality Assurance, CAPAs, Process Improvements, Document Review, Audit Inspection Readiness, Laboratory Operations, and Regulatory Affairs, CAPAs, and the ability to drive to the root cause. Effectiveness in deliverables across a Global Platform.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Global Quality Raw Material Specification Writer
Mars Wrigley
Chicago, IL
09.2021 - Current
- Create, manage, and maintain raw material specifications for legacy Global WWY locations, Co-mans and Ex-mans Specs that enable formulations, production, and supplier contracts.
- Streamlined content creation process, cutting down project turnaround time without compromising on quality.
- Perform technical MRA reviews to guarantee stringent quality, regulatory, and food safety standards.
- Create and manage Centrally Managed Raw Material Specs that enable formulations, production, and supplier contracts.
- Collaborate with PD to provide feedback on spec change request to ensure accuracy to continually improve their processes and specification setup.
- Update specifications, as needed, for reasons such as change of requirements, change of MRA templates, and/or supplier disputes.
- Train Users on Spec Request Process
- Work with MRA Specialists, SQA/Commercial Teams, Global Science Teams, Global QFS, et al to ensure close alignment between MRA, spec requests, and Global Specifications.
- Ensure ongoing maintenance and integrity of raw material specification as key pillars in product creation and traceability, including specification modification’s impact analysis to determine the appropriate course of action.
- Participate in key meetings and work with various teams on projects and assigned rollouts.
- Provide timely, accurate, and succinct updates to multiple stakeholders.
- Key User and Tester for Veritas System – Responsible for End User Onboarding.
- Embrace MARS’ Quality Principles
- Participate in Internal Audits Work with Commercial to navigate through internal and external CAPAs, incidents, and supplier disputes. Maintain Spec Request Data via Metrics Reports
- Managed competing deadlines with efficiency.
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
- Worked flexible hours across night, weekend, and holiday shifts.
- Organized and detail-oriented with a strong work ethic.
- Paid attention to detail while completing assignments.
- Used critical thinking to break down problems, evaluate solutions, and make decisions.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Proved successful working within tight deadlines and a fast-paced environment.
- Developed and maintained courteous and effective working relationships.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Learned and adapted quickly to new technology and software applications.
- Strengthened communication skills through regular interactions with others.
- Managed time efficiently in order to complete all tasks within deadlines.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Demonstrated respect, friendliness, and willingness to help wherever needed.
Quality Assurance Documentation Specialist
Capstone Development Services
Rosemont, IL
04.2020 - 05.2021
- Developed and maintained comprehensive quality assurance documentation to ensure compliance with industry standards.
- Implemented quality control processes, enhancing operational efficiency and reducing documentation errors.
- Collaborated with cross-functional teams to streamline documentation workflows and improve accuracy of project records.
- Conducted thorough reviews of quality documents, identifying discrepancies and ensuring alignment with regulatory requirements.
- Spearheaded efforts to digitize documentation processes, resulting in increased accessibility and reduced retrieval time for project files.
- Facilitated training sessions on quality standards and documentation protocols for team members, enhancing overall team performance.
- Streamlined document processing for increased efficiency by developing and enforcing standardized procedures.
- Performed gap analyses on current processes against industry standards, resulting in actionable recommendations for improvements.
- Contributed to successful audits by meticulously preparing all required documents and responding promptly to information requests from auditors.
- Participated in change management initiatives related to documentation updates, facilitating smooth transitions between old and new procedures.
- Reduced instances of nonconformities by proactively identifying areas for improvement in existing quality systems.
- Maintained comprehensive knowledge of relevant regulatory guidelines, ensuring ongoing compliance within all aspects of quality assurance operations.
- Improved documentation accuracy by conducting thorough quality reviews and implementing necessary revisions.
- Ensured timely completion of audit tasks, demonstrating strong project management skills and attention to detail.
- Continuously monitored the performance of quality management systems, identifying opportunities for optimization and driving continuous improvement efforts.
- Ensure systems and processes within the company’s product development, clinical, commercial manufacturing, and distribution functions operate in accordance with established GxPs’ (Good Laboratory Practice, Good Manufacturing Practice, Good Clinical Practice and Good Distribution Practice) and Industry Guidance Documents.
- Execution and maintenance of Capstone’s Quality Systems. Ensure efficiency, regulatory, compliance, customer satisfaction, and alignment with Capstone’s Quality Management System, including exploring new and improved systems and procedures.
- Provide Quality Assurance expertise, support and services for activities related to existing quality systems and new projects/initiatives to be assessed and/or implemented on site.
- Participate in the preparation and execution of the quarterly Quality Management Review, Audits, and Inspection processes.
- Supervise the corporate Training System and ensuring employee/contractor training files are up to date.
- Train employees on Capstone’s Computer Systems.
- Facilitate all GMP document revisions, including SOPs, specifications, protocols, etc.
- Manage Capstone’s Quality SharePoint Site.
- Ensure all documentation related to Deviations, CAPA’s, Change Control, Complaints, Quality Agreements, Supplier Audits, Supplier Audit Commitments, Risk Management, etc. are properly tracked and archived.
- Maintain relationships and correspondences with all Suppliers regarding CAPAs, Supplier Changes, Supplier Audit Commitments, and Supplier Investigations and Deviations.
- Assist Capstone’s stakeholders for QA items, including, but not limited to preparation of Quality Metrics
Global Products-Regulatory Affairs Coordinator
Takeda Pharmaceuticals North America, Inc.
Deerfield, IL
08.2018 - 09.2019
- Manage (Project Lead) and executing assigned regulatory compliance activities on all levels of complexity in support of Global Regulatory Affairs’ Quality and Compliance Systems, including working with internal and external staff in diverse countries.
- Assist and support Regulatory Compliance activities associated with Takeda’s cross-functional sites and groups, both internally and externally.
- Provide (SME) Subject Matter Expertise in support of Takeda’s Quality Systems utilized in Regulatory Affairs (i.e., eQMS’ Change Control, PRISM, and Spectrum) as it relates to Global Change Controls and GPP (Global Project Plan) creation, as needed.
- Work on projects, i.e., CMC Gap Remediation, Change Control Migration.
- Support the execution of Regulatory Change Controls related to Product Labeling, CMC Changes, Withdrawals, etc. by providing guidance and coordination of Global Regulatory Subject Matter Expert (SME) Impact Assessments.
- Provide and Support awareness and training across Global Regulatory Affairs function to promote an understanding of the execution of Global Change Controls.
- Support Management and the Production of Global Regulatory Affairs Compliance Metrics.
- Led training sessions for staff on regulatory processes and updates to enhance compliance awareness.
- Supported audits by preparing necessary documentation and facilitating communication with regulatory agencies.
- Evaluated internal processes to identify areas for improvement within the context of applicable regulations.
- Implemented robust quality management systems that aligned with both company objectives and regulatory standards.
- Contributed to successful audits by maintaining organized records and preparing comprehensive documentation packages.
- Spearheaded training initiatives to improve employees'' understanding of regulatory requirements and best practices.
- Oversee and monitor Regulatory Processes and Systems.
- Identify, escalate, and propose solutions regarding alignment with Takeda Regulatory Processes and Requirements.
- Review and serve as SME for Global Product Labeling Regulatory Change Control Impact Assessments.
- Prepare reports to track accomplishments and productivity of Change Controls and Global Impact Assessments.
- Coordinate initiatives as assigned by management in support of various Global Regulatory Compliance Projects.
- Developed and maintained regulatory documentation systems for efficient tracking and retrieval of files.
- Collaborated with cross-functional teams to assess product changes and their regulatory impact.
- Reviewed labeling and promotional materials for adherence to regulatory standards before approval.
Education
Bachelor of Science - Biological Sciences
Chicago State University
Chicago, ILSkills
- Genuinely friendly
- Positive attitude
- Team Player
- Problem Solver
Certification
Clinical Research Associate (CRA) @ MITS
Timeline
Global Quality Raw Material Specification Writer
Mars Wrigley
09.2021 - Current
Quality Assurance Documentation Specialist
Capstone Development Services
04.2020 - 05.2021
Global Products-Regulatory Affairs Coordinator
Takeda Pharmaceuticals North America, Inc.
08.2018 - 09.2019
Bachelor of Science - Biological Sciences
Chicago State University
Computer Skills
● Veritas
● Atlas
● SAP (MDG)
● Smartsheet
● Nexus, Salesforce
● ROWA
● Project Lifecycle Management (PLM) - Regulatory Affairs Computer System)
● Master Control
● Empower Chromatographic System
● Millennium Chromatography System
● Chromatography Analytical System (CHROM)
● Laboratory Information Management System (LIMS)
● Business Planning Control System (BPCS)
● Trackwise
● Instrument Maintenance and Calibration System (IMCS)
● SPECTRM
● GxP Learning and Document Management System (LEADS)
● Product Registration Information & Submission Management System (PRISM)
● Electronic Quality Management System (eQMS)
● SharePoint
● Microsoft Office 365 Applications (SharePoint, Excel, Word, PowerPoint, Visio, etc.)
● Docusign