Caprice L. Lyons
Rougemont,USA
Summary
Dynamic Quality and Compliance Specialist adept at managing document control and ensuring compliance with cGMP and GDP regulations. Proven ability to enhance documentation accuracy, streamline processes, and lead teams in successful audit preparation. Committed to fostering a culture of continuous improvement in manufacturing environments.
Overview
24
24
years of professional experience
1
1
Certification
Work History
Senior Document Control Specialist
bioMérieux
Durham, NC
01.2023 - 04.2026
- Managed full document lifecycle including creation, revision, obsoletion, distribution, and archiving, ensuring accuracy and compliance with cGMP.
- Coordinated preparation of audit materials and documentation, ensuring timely responses to auditor inquiries during internal and external audits.
- Monitored compliance with legal and regulatory requirements across manufacturing operations.
- Performed quality assessments and approvals for Change Requests.
- Facilitated Change Request and QMS meetings, managing agendas and schedules to streamline discussions and decision-making.
- Conducted refresher training on SOP and process changes, enhancing understanding among manufacturing teams.
- Approved access control changes to enhance security protocols.
- Utilized systems including SAP, SPC, TrackWise, Live Link, Learning Portal, Bio Access, ACE Auditutopia, ECM, BOM, Bio Apps.
Senior Compliance Manufacturing Specialist
bioMérieux
Durham, NC
09.2019 - 01.2023
- Reviewed manufacturing documentation for compliance with GDP and CPP prior to Batch Release.
- Delivered SOP and process change training across multiple manufacturing lines, enhancing team understanding and compliance.
- Partnered with investigation teams to drive timely corrections and closures of Non-Conformances.
- Conducted interviews and applied 5 Why method to identify root causes, facilitating timely corrective actions.
- Provided on-the-floor document review and supported RFT (Right-First-Time) initiatives.
- Collaborated with Training, Engineering, and Manufacturing to streamline documentation and processes, ensuring regulatory adherence.
- Proficient in Logbook, AQL, rework, inspection, and documentation.
Process Technician
bioMérieux
Durham, NC
11.2018 - 09.2019
- Operated automated equipment, including HMI, case/carton machines, shrink wrap machines, and palletizers, to support efficient production.
- Executed SOPs to maintain accuracy in manufacturing procedures.
- Completed and reviewed documentation to ensure compliance with cGMP standards.
- Followed FDA guidelines for medical device manufacturing and labeling.
- Performed safety audits, inspections, and operated motorized pallet jacks.
- Used SAP to locate product documentation and support manufacturing teams.
Team Leader
AWNC
Durham, NC
06.2011 - 05.2017
- Led a team of 16 employees, ensuring tools, equipment, and resources were available for success.
- Investigated production issues and proposed actionable solutions to improve workflow efficiency.
- Implemented a Kaizen notification system that reduced overtime by 10% and lowered costs.
- Identified root causes of recurring machine faults, reducing faults by 50%.
- Developed work instructions, quality check sheets, and standardized work procedures to enhance operational consistency.
- Coordinated inventory management and supply ordering to support seamless daily production.
- Ensured documentation accuracy at the end of each shift.
Group Leader
Eaton Corporation
Roxboro, NC
06.2002 - 09.2009
- Monitored team compliance with quality and production standards, enhancing overall output.
- Coordinated daily production activities to optimize workflow.
- Facilitated process continuity between shifts by ensuring precise data entry.
- Assembled lash adjusters and calibrated machines daily.
- Read blueprints and used calibration tools including etamic gages.
- Performed physical inventory and ensured material availability.
Education
Associate Degree - Business Management, Medical Technology
Piedmont Community College
Charlotte, NC01-2018
Bachelor of Science - Business Management
University of Phoenix
Charlotte, NCSkills
- Document Control & Lifecycle Management
- SOP development
- FDA & Regulatory Compliance
- Change control
- Non-conformance investigations
- Quality & Safety Control
- Process improvement
- CGMP
- GDP
- TrackWise
- SAP
- Live Link
- ECM
- BOM
- SPC
- Communication
Certification
- Six Sigma Certified
- Critical Conversations
- Dealing with Difficult People
- Motivating People
- Making High-Quality Decisions
- Better Relationships
Volunteer Experience
- Projects of Hope, Board Member
- WOCC, Resource Volunteer
Timeline
Senior Document Control Specialist
bioMérieux
01.2023 - 04.2026
Senior Compliance Manufacturing Specialist
bioMérieux
09.2019 - 01.2023
Process Technician
bioMérieux
11.2018 - 09.2019
Team Leader
AWNC
06.2011 - 05.2017
Group Leader
Eaton Corporation
06.2002 - 09.2009
Associate Degree - Business Management, Medical Technology
Piedmont Community College
Bachelor of Science - Business Management
University of Phoenix