Colby Williamson
Lexington
Summary
Pharmaceutical microbiology professional with a robust background in quality control and laboratory management. Expertise in USP microbiology test methods, including microbial identification, sterility, microbial limits, microbial bioburden, particulate matter, container closure integrity, and bacterial endotoxin testing. Experience operating within systems such as MODA, LabVantage, pyros eXpress, Pharmspec, and PIMS. Currently leading a QC microbiology lab to ensure product safety and compliance with regulatory standards.
Overview
1
1
Certification
8
8
years of professional experience
Work History
Microbiology Quality Control Manager
Nephron Pharmaceuticals
West Columbia
02.2024 - Current
- Developed weekly testing schedule for analysts to optimize workflow and ensure timely testing.
- Reviewed regulatory documents to ensure compliance with pharmaceutical guidance, supporting audit readiness.
- Update test methods and procedures to ensure they align with current pharmaceutical guidance.
- Review and approve Microbiology test method results for lot release.
- Managed daily operations of microbiology personnel, guaranteeing timely task completion.
- Review and approve training documents for laboratory personnel.
- Collaborated with cross-functional teams to address and resolve quality-related issues, enhancing product integrity.
- Implemented corrective actions to address non-conformities in production.
- Participated in regulatory audits from FDA, DEA, and boards of pharmacy.
Microbiology Supervisor
Nephron Pharmaceuticals
West Columbia
09.2022 - 02.2024
- Performed managerial review of microbiology test data.
- Conducted microbiology investigations for OOS and OOT results.
- Revised standard operating procedures to ensure compliance
- Conducted interviews to evaluate and select qualified candidates for new positions.
- Ensure others are following the procedures accurately.
- Reviewed Individual's training certifications to ensure they are complete and accurate.
- Attended BEST training hosted by Millipore sigma and Associates of Cape Cod. Trained on current USP application of Bioburden, Endotoxin, and Sterility test methods.
Quality control microbiology lead
Nephron Pharmaceuticals
West Columbia
07.2021 - 09.2022
- Created schedules for shift employees working in the microbiology lab
- Performed reviews of microbiology samples in laboratory systems such as MODA/LabVantage
- Responsible for troubleshooting issues that may arise during associated shift.
- Performed independent training performances to qualify individuals for testing.
- Completed testing for various test methods such as quality control of incoming materials, 14-day sterility, bacterial endotoxin (turbidimetric), particulate matter, microbial identifications, microbial limits, and microbial bioburdenen.
Quality Control Microbiologist
Nephron Pharmaceuticals
West Columbia
07.2020 - 07.2021
- Performed particulate matter testing on finished product and stability samples
- Performed bacterial endotoxin testing on finished product, in-process, stability, and water for injection
- Performed dye ingress testing on stability and finished product
- Performed rapid sterility testing on stability and finished product testing
- Performed 14-day sterility testing on stability and finished product testing
- Quality control testing of microbiology lab materials such as media and rinse fluids
- Performed sterility check testing on viral transport medium
- Performed testing of biological indicators
Microbiology Lab Technician
Nephron Pharmaceuticals
West Columbia
07.2019 - 06.2020
- Conducted microbial bioburden testing via membrane filtration on in-process , stability, raw materials, components, and water samples.
- Performed genus to species level microbial identifications using advanced techniques on the MALDI-TOF system.
- Performed enumeration on microbial test plates for bioburden and environmental/personnel monitoring.
- Completed gram staining and lactophenol cotton blue staining to facilitate microorganism classification and analysis
- Performed quadrant isolation streaks for microorganisms
- Prepared culture media and reagents for various microbiological tests.
- Assisted in training new staff on laboratory protocols and safety procedures.
Environmental Monitoring Technician
Nephron Pharmaceuticals
West Columbia
06.2018 - 07.2019
- Assisted in training new staff on monitoring protocols and safety procedures.
- Implemented improvements in monitoring techniques to enhance workflow efficiency.
- Collected water for injection samples
- Enumerated environmental monitoring plates
- Performed personnel monitoring for employees in production environments
- Worked in data systems like LabVantage and MODA
- Monitored production processes for compliance with safety and quality standards.
Education
Bachelor's degree - Biology
College of Charleston
Charleston, SC05-2018
Skills
- Technical writing
- Quality assurance
- Laboratory procedures
- Laboratory experience
- CGMP
- Computer skills
- Risk management
- Laboratory management
- Quality control
- Word processing
- Computer literacy
- Microbiology
- Statistical analysis
- Microscopy
- Microsoft Excel
- Cost accounting
- Aseptic technique
- Management
- Microsoft Powerpoint
- Microsoft Word
- APIs
- Leadership
Certification
- Completed Best training hosted by Millipore Sigma for Bioburden, endotoxin, and sterility testing.
Timeline
Microbiology Quality Control Manager
Nephron Pharmaceuticals
02.2024 - Current
Microbiology Supervisor
Nephron Pharmaceuticals
09.2022 - 02.2024
Quality control microbiology lead
Nephron Pharmaceuticals
07.2021 - 09.2022
Quality Control Microbiologist
Nephron Pharmaceuticals
07.2020 - 07.2021
Microbiology Lab Technician
Nephron Pharmaceuticals
07.2019 - 06.2020
Environmental Monitoring Technician
Nephron Pharmaceuticals
06.2018 - 07.2019
Bachelor's degree - Biology
College of Charleston