Kaye Woodward
Altria Client Services
Verona
1
Certification
33
years of professional experience
Detail-oriented document control coordinator with experience managing revisions, archives, and change control in regulated environments. Brings strong project management, communication, and version control skills to maintain accurate records and smooth document lifecycles. Ready to support efficient, compliant operations.
Work History
Document Control Coordinator
1 Year 5 Months- Managed document control requests, ensuring accurate routing, approval tracking, and timely distribution of revisions.
- Maintained controlled records, folders, and archives in compliance with company retention requirements.
- Reviewed documents for formatting, version control, and completeness before release into shared systems.
- Coordinated with cross-functional teams to update procedures, forms, and work instructions.
- Supported change control activities by processing updates and verifying document history accuracy.
- Communicated status updates on pending approvals, pending revisions, and document lifecycle changes.
Senior Specialist, Quality Assurance
7 Years 11 Months- Developed standardized SOPs to improve accuracy, consistency, and team execution.
- Coordinated regulatory documentation and internal approvals for timely submission readiness.
- Mentored team members on systems, processes, and quality expectations.
Quality - Contractor
6 Months- Managed contracted project tasks, ensuring deliverables aligned with client requirements and deadlines.
- Reviewed documentation for accuracy, completeness, and consistency before final submission.
- Communicated progress updates, risks, and resource needs to maintain project visibility.
Principal Process Improvement Analyst
1 Year 2 Months- Led process improvement efforts to define, map and improve the effectiveness and efficiency of processes.
- Facilitated the development of process solutions.
- Managed the development and implementation of change management plans.
- Developed tools and approaches to support process improvement initiatives.
Lab Manager, Operational Excellence
5 Years 8 Months- Created, tracked, and trended efficiency, productivity, quality, and financial metrics for GMP business.
- Identified and assisted in organization and implementation of process improvement initiatives.
- Collaborated and worked cross-functionally across all levels of personnel and business units within GMP Labs and PPD.
- Supervised a group of 3 direct reports.
Lab Manager
3 Years 8 Months- Responsible for project/program management within R&D department.
- Created, tracked, and trended financial and quality metrics across the R&D department.
- Identified where process improvements are needed based on available metrics.
- Assisted Director with departmental business analysis.
Senior Group Leader
8 Years 1 Month- Promoted from Associate to Senior Group Leader.
- Supervised 8-12 team members in all aspects of operations including scheduling, personnel management, training, mentoring, compliance, and resolution of technical issues.
- Served as project manager for multiple concurrent projects, including primary client contact, adherence to budget, timelines, quality, client requirements.
Project Leader
4 Years 2 Months- Promoted from Scientist to Project Leader.
- Responsibilities included project management, client contact, document preparation, compliance, and preventative and routine maintenance of analytical equipment.
- Independently performed sample preparation, analysis, the documentation of stability and release studies for a variety of pharmaceutical product types using HPLC, FTIR, UV/VIS, dissolution, and other quantitative and qualitative means according to GMP regulatory requirements.
- Creation and review of protocols, specifications, and deviations to ensure cGMP-compliant laboratory operations.
- Led GMP lab project execution, aligning testing priorities with client deliverables and compliance requirements.
Education
Bachelor of Science - Biology / Chemistry
Skills
Document control
Regulatory compliance
Change management
Process improvement
Lean Six Sigma Green Belt
Project management
Certification
Lean Six-Sigma Green Belt certification - June 2014
Timeline
Document Control Coordinator
Altria Client Services
05.2025 - CurrentRead More
Senior Specialist, Quality Assurance
NJOY
06.2017 - 05.2025Read More
Quality - Contractor
Reveritas Group LLC
12.2016 - 06.2017Read More
Principal Process Improvement Analyst
PPD
10.2015 - 12.2016Read More
Lab Manager, Operational Excellence
PPD - GMP Labs
01.2010 - 09.2015Read More
Lab Manager
PPD - GMP Labs
05.2006 - 01.2010Read More
Senior Group Leader
PPD - GMP Labs
04.1998 - 05.2006Read More
Project Leader
PPD - GMP Labs
02.1994 - 04.1998Read More
Univeristy of Wisconsin - Eau Claire
Bachelor of Science from Biology / Chemistry
Read More