Quality Assurance Specialist experienced in pharmaceutical and biotech industries. Achieved improvements in product quality and operational efficiency through effective quality control initiatives and strategic process enhancements. Focused on ensuring regulatory compliance and fostering a culture of continuous improvement.
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Hi, I’m
Tonya Richardson
Wake Forest,NC
Summary
Work History
Iqvia Laboratories Durham, North Carolina
Quality Specialist
11.2021 - Current
Job overview
- Perform Quality review of documentation such as Sample Login binders, run binders, extraction paperwork, Lab notebooks, Data tables, and reports.
- Evaluated quality assurance documentation to ensure adherence to industry standards, contributing to regulatory compliance.
- Participate in review of technical SOPs to ensure compliance with appropriate regulations.
- Trained staff on quality standards and best practices in laboratory settings.
- Assisted in the preparation of regulatory submissions and inspections.
- Monitored laboratory equipment to ensure proper calibration and functionality.
- Organized and maintained records of test results, QC, and QA activities to ensure accurate tracking and reporting.
- Facilitated operations through detailed documentation support, enhancing clarity and accessibility.
PfizerRocky Mount, North Carolina
Quality Assurance Specialists III
08.2019 - 01.2021
Job overview
- Served as primary quality assurance contact, monitoring production processes to ensure compliance with Good Manufacturing Practices standards.
- Inspection results and appropriate testing to support product release.
- Reviewed and analyzed test results to ensure adherence to industry regulations.
- Obtained samples for long-term storage, facilitating stability testing and annual retention inspection.
- Obtained certification as a controlled drug agent to ensure compliance with regulations.
- Reviewed and analyzed test results, ensuring compliance with industry regulations.
Promethera BioscienceDurham, North Carolina
Production Specialist
12.2016 - 08.2019
Job overview
- Aseptic production of human primary cell using accompanying documentation according to cGMP guidelines, Phase I and II of Clinical trials.
- Implemented GMP processes for improvements, screened medical records, and prepared media fills and cell isolations for retention and reference samples.
- Perform and assist in coordination of raw materials purchase request.
- Monitored production processes to ensure quality standards were met.
- Documented production data and maintained accurate records for audits.
- Coordinated cross-functional teams to achieve project timelines and deliverables.
- Monitored production processes to maintain compliance with quality standards.
- Completed Aseptic Process I certification
Education
NORTHERN NASH HIGH SCHOOLROCKY MOUNT, NORTH CAROLINA
High school
University Overview
Skills
- Regulatory Compliance
- cGMP
- GLP
- SOPs
- Batch Record Review
- Analytical testing
- Quality metrics
- Change Controls
- Document control
- Process monitoring
- Manufacturing Process
- Materials ordering
Timeline
Quality Specialist
Iqvia Laboratories
11.2021 - Current
Quality Assurance Specialists III
Pfizer
08.2019 - 01.2021
Production Specialist
Promethera Bioscience
12.2016 - 08.2019
NORTHERN NASH HIGH SCHOOL
High school
06.1999