Quanesha Gonzales
Grimesland
Summary
Senior Quality Assurance Technician specializing in cGMP compliance and quality systems. Expertise in batch record review and deviation management, driving continuous process improvements. Strong analytical skills contribute to regulatory adherence and operational efficiency.
Overview
12
12
years of professional experience
Work History
Senior Quality Assurance Technician
Thermo Fisher Scientific
07.2022 - Current
- Ensure adherence to quality assurance protocols across material processing and finished product manufacturing
- Review batch records and in-process documentation for compliance with cGMP standards
- Identified and supported investigations of product deviations and non-conformances, ensuring timely resolution and compliance
- Analyzed production data to identify trends, enabling targeted process improvements and enhanced quality outcomes
- Support clinical trial packaging operations and ensure regulatory compliance
- Conduct audits of facility, personnel, and documentation
- Provided GMP guidance and troubleshooting support, facilitating adherence to regulatory standards and operational efficiency
- Participate in deviation response and quality improvement initiatives
Formulation Technician II
Thermo Fisher Scientific
07.2019 - 07.2022
- Executed formulation processes, ensuring compliance with SOPs and GMP requirements to maintain product quality
- Prepared raw materials and ensured accuracy through quality checks
- Operated and troubleshot manufacturing equipment, minimizing downtime and optimizing production flow
- Maintained accurate batch records and documentation
- Collaborated with teams to streamline manufacturing processes, enhancing overall operational efficiency
Return to Manufacturer Clerk
Lowe’s
01.2014 - 07.2019
- Managed product returns and vendor communications to streamline order processing
- Resolved customer issues while upholding service standards to enhance customer satisfaction
- Collaborated with logistics teams to identify and resolve operational issues, improving workflow
- Supported sales teams with quotes and tracking
Education
High School Diploma -
SouthWest Edgecombe High School
Pinetops, NCSkills
- Quality assurance
- CGMP compliance
- Batch record review
- Auditing practices
- Deviation investigation
- CAPA management
- SOP review
- Risk management
- Process improvement
- Data analysis
- Clinical trial support
- Manufacturing operations
Timeline
Senior Quality Assurance Technician
Thermo Fisher Scientific
07.2022 - Current
Formulation Technician II
Thermo Fisher Scientific
07.2019 - 07.2022
Return to Manufacturer Clerk
Lowe’s
01.2014 - 07.2019
High School Diploma -
SouthWest Edgecombe High School