Kesha Woodard
Houston,TX
Summary
Detail-oriented Quality Assurance Documentation Specialist with 5+ years of experience in implementing and managing documentation processes within the pharmaceutical industry. Proven expertise in TrackWise, Veeva Vault, QMS, CTMS, and EDC systems. Seeking an opportunity to leverage skills and experience in a dynamic organization dedicated to maintaining high-quality standards and regulatory compliance.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Quality Assurance Documentation Specialist
Verified Resources
01.2023 - Current
- Managed end-to-end document control process, including the creation, review, approval, distribution, and archival of critical documents using QMS.
- Conducted regular reviews of document workflows to identify and address bottlenecks, ensuring timely document submissions.
- Collaborated with external auditors to facilitate documentation reviews and responded to audit findings with corrective actions.
- Prepared and maintained reports on document control metrics, providing insights into trends and areas for improvement.
Quality Assurance Documentation Specialist
AVEO Oncology
03.2021 - 01.2023
- Implemented and managed TrackWise, Veeva Vault, and other electronic document management systems to ensure the accuracy, completeness, and compliance of project documentation.
- Developed and maintained comprehensive Quality Management System (QMS) documentation, including SOPs, work instructions, and quality records.
- Conducted regular audits of documentation processes to identify areas for improvement, ensuring alignment with regulatory requirements and company policies.
- Collaborated with cross-functional teams to streamline document workflows and improve efficiency in the document control process.
- Provided training to team members on the use of TrackWise, Veeva Vault, and other systems, ensuring a high level of proficiency and adherence to quality standards.
- Coordinated with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) teams to integrate document control processes seamlessly into clinical trials.
Clinical Project Associate
KITE Pharmaceutical
11.2021 - 04.2022
- Established strong relationships with key stakeholders, facilitating effective communication across departments and teams.
- Updated inspection journals and daily summary logs with quality-related data.
- Followed safety protocols while handling hazardous materials.
- Maintained accurate records of all quality-related activities, ensuring compliance with regulatory requirements.
- Maintained open lines of communication with regulatory agencies, ensuring the organization remained in compliance with all applicable standards and industry regulations.
- Streamlined quality control procedures by developing and implementing standardized checklists for consistent inspections.
Adjudication Specialist II
Covance
12.2018 - 02.2020
- Functional project management of endpoint case processing and adjudication deliverables.
- Receiving and processing events for adjudication, working to collect event data and documents required for adjudication, working within adjudication event tracking systems.
- Case processing for investigator-reported endpoints and triggered events, endpoint data, and document collection and preparation
- Project file maintenance, archiving, and transfer
Education
Bachelor of Science -
North Carolina Central University
Durham, NC05.2020
Skills
- Document Control
- Standard Operating Procedures
- Document Management
- Clerical Support
- Research
- Troubleshooting
- Multitasking
- Relationship Building
- Customer Relations
- Organization
- Attention to Detail
- Veeva-Vault, CTMS, EDC and Track-wise Software Proficiency
- Decision-Making
Certification
- BioWork, Wake Technical Community College
- Vulnerability Management Detection and Response Certificate, Qualys
Timeline
Quality Assurance Documentation Specialist
Verified Resources
01.2023 - Current
Clinical Project Associate
KITE Pharmaceutical
11.2021 - 04.2022
Quality Assurance Documentation Specialist
AVEO Oncology
03.2021 - 01.2023
Adjudication Specialist II
Covance
12.2018 - 02.2020
Bachelor of Science -
North Carolina Central University
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