Tonya Brown
Burlington
Summary
Quality Specialist with extensive experience in quality assurance within pharmaceutical and food manufacturing. Leadership in managing CAPA initiatives and fostering high-performance teams has driven operational excellence and ensured compliance with FDA and ISO standards.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Quality Specialist
Merck
Durham
10.2016 - Current
- Conducted quality inspections on products, ensuring adherence to industry standards and regulatory requirements
- Collaborated with cross-functional teams to identify root causes of quality issues and implement corrective actions
- CAPA ownership and GDP/GMP compliance with ALCOA principles
- Performed regular quality checks on manufacturing processes to ensure compliance with established quality standards
- Led training sessions for production staff on quality data integrity techniques and best practices with implemented areas for improvement
- Maintained documentation of all quality assurance activities, including GMP documentation, SOPs, test results, and non-conformance reports
- Identified opportunities for cost savings through process optimization without compromising product integrity
- Mentored junior members of the QA team by providing guidance on best practices
- Led internal training programs on quality assurance principles, practices, and tools
- Conducted regular internal meetings to assess compliance with company policies, procedures, and industry regulations
- Developed and maintained documentation of standard operating procedures (SOPs) for quality control processes
- Collaborated with production teams to implement process controls and statistical methods for critical manufacturing steps and process validation qualification
- Participated in meetings to address questions or concerns regarding product quality standards
- Collaborated with customer service teams to address customer complaints or inquiries regarding product quality issues
Quality Technician II
Convatec Inc
Greensboro
12.2013 - 09.2016
- Evaluated manufacturing processes for Class III medical devices to ensure compliance with FDA, ISO, and quality regulations, identifying potential quality issues using problem-solving techniques.
- Executed quality inspections on incoming materials to verify compliance with specifications and standards.
- Performed documentation, calculations, and document reviews for pharmaceutical products and medical devices.
- Ability to work in high performance team structure. Assists with CAPA process through completion. Coordinate and collaborate to pinpoint abnormalities for further traveling analysis.
- Coordinated safety practices and implemented health management systems as a Carolina Star safety coordinator.
Manufacturing Technician III
Convatec Inc
Greensboro
10.2013 - 12.2013
- Managed GMP documentation, SOPs, product testing, and data recording to maintain quality standards.
- Documented and reviewed calculations and processes to ensure manufacturing compliance with regulatory standards.
- Performs routine quality testing and inspection functions for product specifications.
- Facilitated root cause analysis meetings and provided training to enhance team communication and problem-solving skills.
- Work effectively in high performance work environment. Strong background in operation & quality and maintenance of production.
Manufacturing Technician III / QA Technician II
MOM Brands Cereal Company
Asheboro
09.2008 - 10.2013
- Monitored product quality at production stages through testing tools and visual inspections, ensuring adherence to quality standards.
- Operated and maintained manufacturing equipment to ensure optimal performance and compliance with quality standards.
- Conducted inspections and troubleshooting to identify and resolve machinery issues, minimizing downtime.
- Collaborated with cross-functional teams to implement process improvements, enhancing efficiency.
- Led control room processes by automating systems in high-level manufacturing environments.
- Maintained documentation of production activities, including inventory and quality control reports, to support compliance and operational efficiency.
- Followed standard operating procedures for safety, ensuring a secure working environment for employees.
- Participated in cross-training programs to broaden skills across diverse manufacturing operations.
Manufacturing Operator
Miller Brewing Company
Eden
02.2007 - 08.2007
- Manufactured brewed products on a high-volume product line.
- Operated and maintained production machinery, ensuring efficient and accurate manufacturing processes
- Responsible for fabrication of brewed beer formulation. Process daily operation of machinery of product specifications and production.
- Monitored machine performance and adjusted settings to optimize productivity and minimize downtime of brewing equipment.
- Patrolled and monitored equipment and process conditions to ensure compliance with procedures and regulations.
- Collaborated with team members to achieve production goals and deadlines, communicating challenges and bottlenecks effectively.
- Conducted regular quality checks on finished products using measuring instruments or visual inspection methods as per specifications provided by quality control department
- Followed established work instructions precisely to ensure consistent product quality throughout the manufacturing process
Education
B.A. - Sociology
Greensboro College
Greensboro, NC05-2021
A A & S - Science
Patrick Henry Community College
Martinsville, VA01-1993
A A & S - Liberal Arts
Patrick Henry Community College
Martinsville, VA01-1993
Skills
- Quality assurance
- Quality control
- Quality audits
- Manufacturing quality assurance
- Pharmaceutical manufacturing
- Laboratory experience
- Food safety
- GMP
- CGMP
- FDA regulations
- FDA 21 CFR Part 11
- Hazardous materials compliance
- Environmental compliance
- OSHA
- Continuous Improvement
- Process improvement standards implementation
- Implementing lean manufacturing processes
- Six Sigma
- 5S
- Quality inspection
- Quality assurance audits
- CAPA
- CAPA implementation
- Compliance auditing
- Analysis skills
- Engineering validation
- Cleanroom
- Industrial hygiene
- Manufacturing company experience
- Coordinate measuring machine
- Microsoft Excel
- Microsoft Office
- Productivity software
- Training design
- Continuous improvement standards
- Manufacturing
- CAPA implementation
- ISO
- Continuous improvement standards
Certification
- HACCP Certification, 12/01/08, Present
- Certified Quality Technician
- Driver's License
- Six Sigma Certification
Additional Information - Work Authorization
Authorized to work in the US for any employer
Timeline
Quality Specialist
Merck
10.2016 - Current
Quality Technician II
Convatec Inc
12.2013 - 09.2016
Manufacturing Technician III
Convatec Inc
10.2013 - 12.2013
Manufacturing Technician III / QA Technician II
MOM Brands Cereal Company
09.2008 - 10.2013
Manufacturing Operator
Miller Brewing Company
02.2007 - 08.2007
B.A. - Sociology
Greensboro College
A A & S - Science
Patrick Henry Community College
A A & S - Liberal Arts
Patrick Henry Community College