Kema Sanders
Durham,NC
Summary
Efficient and organized professional with over 10 years of experience in the Pharmaceutical & Biomedical fields concentrating in Quality Assurance, Document Control, Regulatory Affairs, Records Management, with solid organizational, analytical skills, with a high level of attention to detail.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Specialist
Grifols Inc.
Research Triangle Park, NC
09.2021 - Current
- Received, researched and resolved consumer inquiries.
- Monitored post-market surveillance activities, identifying trends and addressing any potential safety concerns promptly.
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
- Facilitated productive communication between company management and regulatory agencies, fostering positive relationships.
- Recommended improvements to processes.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Developed or tracked quality metrics.
- Maintained and archived regulatory paperwork.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Completed and reported on [Product or Service] impact assessments.
- Prepared and submitted regulatory file applications and supporting documentation.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Manage product teams of [Number] for regulatory product compliance on [Product or Service].
Records Management Coordinator (Regulatory Affairs)
Grifols, Inc.
01.2012 - 09.2021
- Managed document control for electronic and hard copy regulatory records
- Assist with packaging of documents for FDA Approvals and Amendments
- Responded to management inquiries regarding regulatory submissions
- Handled licensing, registrations, and audits to support business operations
- Tracked progress of regulatory submissions and notifications via database tracking system
- Supported co-workers with monitoring and verifying current medical licenses for the laboratory directors
- Coordinated and processed invoices for registration, licensing, compliance, and accreditation
- Completed contact reports for communications with governmental/regulatory agencies
- Assist in the implementation, daily operation, and future expansion of the Corporate Records and Information Management Program for both paper and electronic records by providing consultation services, training, and education to staff about the program and providing guidance to employees in all aspects of records management
- Promote best practices in electronic records management and migrate paper records to electronic storage
- Assist with implementation and maintenance of the records management program.
- Carried out in-depth needs assessments to determine document management requirements at department and individual user levels.
- Coordinated offsite storage solutions for physical records, maintaining easy access when required.
Quality Systems Document Coordinator
Talecris Plasma Resources
03.2008 - 01.2012
- Reviewed accuracy of submitted PIRs and MIRs
- Initiated corrective action of incorrect/incomplete PIRs and MIRs
- Prepared PIRs, MIRs, for review by corporate medical director and FDA
- Entered confidential high-level donor and investigational information into the online tracking system
- Scanned index critical documentation into archival databases
- Assisted plasmapheresis centers with KPI and deviation reporting
- Ensuring compliance with current regulations
- Monitoring and reporting on all activities, processes, and procedures
- Developing internal auditing tools and conducting internal audits and reports
- Determining data-driven solutions and implementing quality improvement plans
- Performing regular inspections and reviews to ensure employees adhere to quality and safety policies
- Assisting with the development of company policies, processes, and procedures
- Providing departments with quality planning and support
- Conducting or assisting with regulatory and quality training sessions
- Preparing and maintaining quality management documentation.
Document Control and Records Specialist
GlaxoSmithKline
04.2006
- Managed FDA regulated SOPs such as Validation, Quality, Change Control and Document Control
- Document management of electronic and hard copy files to ensure that all procedures were complete, current and ready for implementation by staff
- Worked closely with the Auto-CAD and Engineering Departments
- Scanned and Bookmarked drawings and blueprints for architectural structures on all GSK Properties
- Adhered to GSK guidelines and regulations and well as industry regulations
- Prepared documents for archiving into a Pier / Documentum database for client access
- Trained internal customers as well as colleagues on the use of the Pier / Documentum database
- Scanned and indexed documentation in preparation for archival
- Formatted documents to standard layout requested by internal customers
- Controls company and project documentation
- Follows and improves document control procedures
- Ensuring all documentation meets formal requirements and required standards
- Sorting, storing, and retrieving electronic and hard copy documents on behalf of clients and industry professionals
- Producing document progress reports for senior managers
- Conducting regular reviews and document audits
- Using computers to organize and distribute documents within a company
- Helping in the planning stages of a specific project
- Ensure documents are shared at key times to facilitate timely project completion.
Customer Support Agent
Etix
Morrisville, NC
03.2018 - Current
- Contributed to the development of internal training materials, boosting team efficiency in assisting customers more effectively.
- Created user accounts and assigned permissions.
- Developed comprehensive knowledge of company products and services to better assist customers with their individual needs.
- Maintained customer satisfaction with forward-thinking strategies focused on addressing customer needs and resolving concerns.
- Managed high-stress situations calmly and professionally while maintaining excellent rapport with clients during difficult conversations or escalations.
- Broke down and evaluated user problems, using test scripts, personal expertise, and probing questions.
- Actively listened to customers, handled concerns quickly and escalated major issues to supervisor.
- Answered constant flow of customer calls with minimal wait times.
- Enhanced customer satisfaction by promptly addressing and resolving support inquiries.
- Answered customer telephone calls promptly to avoid on-hold wait times.
- Researched and identified solutions to technical problems.
Education
No Degree - Quality Assurance
Grifols Inc. Glendale Academy
Glendale, AZ08.2014
Certification - GMP and SOP Procedures
Durham Technical Community College
Durham, NC09.2013
Certification - Bio Works and Basic Laboratory Methods I and II
Durham Technical Community College
Durham, NC12.2005
North Carolina Central University
Durham, NC11.1997
Skills
- Excel
- Outlook
- PowerPoint
- Leadership
- Microsoft Office Suite
- Interpersonal Communication
- Risk Management and Compliance
- Problem Resolution
- Public Speaking
- Time Management
- Attention to detail, accuracy, and quality
- Strong Researcher, Analyze Data
- Records Management
- Customer Service Management
- Strategic Thinker
- Organizational, Multi-tasking
- Account Management
- Legal requirements
- Report Preparation
- Compliance Monitoring
- Records Review
- File conversion
- Records Management Systems
Certification
- [Area of expertise] License - [Timeframe]
Notary Public
public officers appointed by state governments to serve the public as impartial witnesses
Timeline
Regulatory Affairs Specialist
Grifols Inc.
09.2021 - Current
Customer Support Agent
Etix
03.2018 - Current
Records Management Coordinator (Regulatory Affairs)
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
No Degree - Quality Assurance
Grifols Inc. Glendale Academy
Certification - GMP and SOP Procedures
Durham Technical Community College
Certification - Bio Works and Basic Laboratory Methods I and II
Durham Technical Community College
North Carolina Central University