Justin Ramsey
Louisville,KY
Summary
Seasoned Quality Control Manager with experience in quality assurance, process improvement, and regulatory compliance. Possess strong leadership skills and expertise in implementing effective quality control procedures. Previous work has led to improved efficiency, reduced costs and enhanced product quality.
Overview
9
9
years of professional experience
Work History
Quality Control Manager/Quality Assurance Associate II
CreoSalus, Inc
Louisville, USA
10.2022 - Current
- Provide technical, GLP, and organizational leadership to the QC Laboratory to ensure staff have adequate resources and training to perform their duties in full GMP/GLP compliance.
- Support FDA inspections and customer audits.
- Lead laboratory investigations and root cause analyses.
- Author and maintain test methods, specifications, process and method validations, and standard operating procedures (SOPs) defining laboratory activities.
- Enforce cGMP/GLP compliance and adherence to 21 CFR Part 11 regulations across the laboratory.
Process Quality Technical Lead
Bakelite Synthetics
Louisville, USA
08.2020 - 10.2022
- Led technical investigations and supported Root Cause Analyses (RCAs) to resolve global customer complaints.
- Researched and implemented process improvement developments.
- Conducted Gage Repeatability and Reproducibility (R&R) and Round Robin testing to establish control samples and instrument control charting.
- Prepared sites for regulatory compliance audits.
Quality Control Chemist/Peptide Manufacturing Chemist/ Project Lead/ MFG Team Lead
CreoSalus, Inc
Louisville, USA
02.2017 - 08.2020
- Spearheaded cost-saving project for cleaning and regenerating preparative HPLC columns.
- Maintained and troubleshot Thermo, Shimadzu and Waters instruments, resolving hardware and software issues.
- Designed, executed and reported instrument validation studies.
- Coordinated large-scale projects with cross-functional teams.
- Collaborated with Thorn BioScience to develop analytical methods for porcine Deslorelin Acetate.
Analytical Technologist/Safety Committee Member
Dow Chemical
Louisville, USA
06.2015 - 02.2017
- Managed SQC samples, certified reference materials and SQC charts using NWA software.
- Redesigned methods and analyses to align with lean lab practices.
- Performed routine and non-routine maintenance, ensuring quality control for various instruments.
- Spearheaded site implementation of new test methods and instruments.
Education
Bachelor of Science - College of Agriculture/Biotechnology
Purdue University
West Lafayette, IN12.2011
Skills
- cGxP (7 years)
- Chromatography (10 years)
- FDA Inspection experience
- Project Management
- Regulatory Compliance
- Quality Management Systems
- Small Molecule Manufacturing and Analysis
References
References available upon request.
Timeline
Quality Control Manager/Quality Assurance Associate II
CreoSalus, Inc
10.2022 - Current
Process Quality Technical Lead
Bakelite Synthetics
08.2020 - 10.2022
Quality Control Chemist/Peptide Manufacturing Chemist/ Project Lead/ MFG Team Lead
CreoSalus, Inc
02.2017 - 08.2020
Analytical Technologist/Safety Committee Member
Dow Chemical
06.2015 - 02.2017
Bachelor of Science - College of Agriculture/Biotechnology
Purdue University
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