Kema Sanders
Durham
Summary
Detail-oriented and results-driven Regulatory Affairs and Data Management professional with over 15 years of experience in compliance, quality control, and medical data analysis. Adept at interpreting regulatory guidelines, managing large-scale data systems, and ensuring adherence to state and federal regulations. Skilled in auditing, records management, and cross-functional collaboration to enhance operational efficiency. Seeking to leverage expertise in regulatory compliance and data abstraction in a Cancer Registry role.
Overview
19
19
years of professional experience
Work History
REGULATORY AFFAIRS SPECIALIST – LICENSING
Grifols, Inc.
09.2021 - Current
- Managed compliance for over 60+ locations, ensuring adherence to state and federal regulations, including FDA, CLIA, and other regulatory bodies
- Conducted regulatory research, data analysis, and documentation to maintain accreditation and operational compliance
- Spearheaded the development of a regulatory FAQ database, streamlining internal references for compliance inquiries
- Authored standardized communication templates to ensure consistent regulatory messaging
- Prepared and formatted high-quality FDA submissions and licensing applications to meet compliance requirements
- Collaborated with teams to monitor evolving regulations and implement necessary changes
- Conducted internal quality control audits to maintain document accuracy and compliance
- Improved regulatory submission accuracy through enhanced document review processes
- Strengthened relationships with regulatory agencies through proactive communication and engagement
RECORDS MANAGEMENT COORDINATOR
Grifols, Inc.
01.2012 - 09.2021
- Company Overview: formerly Talecris Plasma Resources
- Led data collection, document control, and records management for regulatory submissions and compliance tracking
- Abstracted and maintained patient data in compliance with regulatory and licensing requirements
- Conducted internal audits, quality reviews, and compliance checks to ensure alignment with industry and federal standards
- Developed and implemented a comprehensive records management system to enhance efficiency and accuracy
- Formerly Talecris Plasma Resources
- Spearheaded the integration of electronic records management software, streamlining documentation retrieval and compliance tracking
- Increased data retrieval efficiency through enhanced organization and systematization
QUALITY SYSTEMS DOCUMENT COORDINATOR
Talecris Plasma Resources
03.2008 - 01.2012
- Reviewed and corrected quality deviation reports, ensuring compliance with regulatory standards
- Conducted internal audits and implemented quality improvement strategies
- Created and refined auditing tools to enhance reporting accuracy
- Trained staff on quality assurance practices and documentation procedures
- Improved key performance indicator tracking and deviation reporting through comprehensive audit tool implementation
- Enhanced documentation efficiency and compliance through process improvements
DOCUMENT CONTROL AND RECORDS SPECIALIST
GlaxoSmithKline
04.2006 - 03.2008
- Managed FDA-regulated standard operating procedures (SOPs) and ensured compliance in validation, quality, and change control processes
- Maintained electronic and paper-based record-keeping systems, enhancing data retrieval efficiency
- Provided staff training on document control systems to ensure regulatory adherence
- Reduced document retrieval times through streamlined control procedures
- Increased operational effectiveness by improving document formatting and archival processes
Education
Project Management Certificate -
Durham Technical Community College
04.2024
ASQ Quality Assurance Training Program -
Glendale Academy – Grifols Inc.
08.2014
Good Manufacturing Practices & SOP Certificate -
Durham Technical Community College
09.2013
BioWorks & Basic Laboratory Methods I & II Certificate -
Durham Technical Community College
12.2005
General Studies -
North Carolina Central University
11.1997
Skills
- Medical Data Abstraction & Compliance
- Case Documentation & Record Auditing
- Quality Control & Regulatory Adherence
- Data Coding, Sequencing & Staging
- Database Management & Analysis
- Cross-functional Collaboration & Client Support
- Risk Assessment & Corrective Actions
- Process Improvement & SOP Development
- FDA Submissions & Document Control
- Microsoft Office Suite (Excel, PowerPoint, Outlook)
- Regulatory compliance
- Quality assurance
- Document control
- Records management
- Effective communication
- Attention to detail
- Problem solving
- Time management
- Excellent communication
Timeline
REGULATORY AFFAIRS SPECIALIST – LICENSING
Grifols, Inc.
09.2021 - Current
RECORDS MANAGEMENT COORDINATOR
Grifols, Inc.
01.2012 - 09.2021
QUALITY SYSTEMS DOCUMENT COORDINATOR
Talecris Plasma Resources
03.2008 - 01.2012
DOCUMENT CONTROL AND RECORDS SPECIALIST
GlaxoSmithKline
04.2006 - 03.2008
Project Management Certificate -
Durham Technical Community College
ASQ Quality Assurance Training Program -
Glendale Academy – Grifols Inc.
Good Manufacturing Practices & SOP Certificate -
Durham Technical Community College
BioWorks & Basic Laboratory Methods I & II Certificate -
Durham Technical Community College
General Studies -
North Carolina Central University
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