Amber Daniels
Grove City,OH
Summary
Results-driven Quality Professional with 5+ years of experience managing Quality Management Systems (QMS) and leading continuous improvement efforts. Adept at ensuring compliance with industry standards (GDP, GMP, GLP) while employing data analysis, problem-solving, and proactive communication to drive organizational success. Proven leadership ability with a track record of implementing innovative solutions to meet or exceed quality standards.
Overview
6
6
years of professional experience
Work History
QC Lab Supervisor
Bright Innovation Labs
03.2024 - 12.2024
- Led team of over 20 professionals, including chemists, microbiologists, raw material inspectors, component inspectors, document control specialists, and a stability technician.
- Led performance evaluations and staffing assessments to optimize team productivity.
- Conducted data analysis and reporting for internal and external client projects.
- Developed quality assurance strategies by identifying critical control points and preventive measures.
- Ensured adherence to GMP, GLP, and GDP through monitoring of laboratories and inventories.
- Assisted with departmental budgeting and procurement while maintaining cost controls.
- Supported the team during regulatory audits to ensure compliance and readiness.
QC Microbiologist
Bright Innovation Labs
02.2023 - 03.2024
- Performed microbiological testing on raw materials, finished products, and environmental samples.
- Investigated Out-of-Specification (OOS) results and executed root cause analyses.
- Prepared media and performed growth promotion testing to ensure suitable quality.
- Calibrated and maintained laboratory instrumentation to ensure optimal performance.
- Wrote, updated, and maintained SOPs in preparation for audits.
QA Analyst
T. Marzetti
03.2021 - 02.2023
- Conducted environmental and allergen swabs, compiling results for senior management.
- Monitored operational compliance with GMPs to ensure food safety standards were met.
- Collected and analyzed ingredient and product samples, tracking compliance with testing standards.
Microbiology Lab Technician
Nestle Quality Assurance Center
11.2020 - 03.2021
- Prepared and tested microbiological samples, ensuring quality results through accurate testing.
- Operated lab equipment (balances, pH meters, autoclaves, etc).
- Observed potential quality risks and contributed to maintaining QA documentation standards
Phlebotomist
CSL Plasma
07.2018 - 11.2020
- Performed venipuncture and apheresis procedures with accuracy and attention to patient safety.
- Monitored patient vitals and updated comprehensive donor records daily.
- Maintained laboratory cleanliness and equipment sterilization to ensure safety and compliance.
Education
Bachelor of Arts - Biology
Wright State University
Dayton, OH12.2020
Skills
- Laboratory management
- Quality control monitoring
- Quality standards GDP, GMP, GLP
- KPI and CCP analysis
- Data analysis
- Attention to detail
- Critical thinking
- Problem-solving
- Effective communication
- Teamwork
- Adaptability
- Leadership
Accomplishments
- Cap-X Project Leadership: Successfully led the overhaul and implementation of a new Celsis Advance II Machine by overseeing purchasing, installation, and validation. This initiative increased testing accuracy and sped up shipping times—creating additional production capacity.
Timeline
QC Lab Supervisor
Bright Innovation Labs
03.2024 - 12.2024
QC Microbiologist
Bright Innovation Labs
02.2023 - 03.2024
QA Analyst
T. Marzetti
03.2021 - 02.2023
Microbiology Lab Technician
Nestle Quality Assurance Center
11.2020 - 03.2021
Phlebotomist
CSL Plasma
07.2018 - 11.2020
Bachelor of Arts - Biology
Wright State University
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