Carl Gustin
Grand Haven
Summary
Versatile pharmaceutical scientist with comprehensive experience spanning microbiology and chemistry. Formerly responsible for the sole operation of a Microbiology lab, demonstrating exceptional self-management and technical accountability. Progressed to the current Chemist position, mastering a broad range of analytical methodologies. Recognized for an edification-focused work ethic, managing competing priorities without sacrificing data integrity, and compliance. Committed to maintaining peak laboratory standards and meeting critical manufacturing deadlines through superior time management.
Overview
4
4
years of professional experience
Work History
Quality Control Chemist I
SPI Pharma
Grand Haven
04.2025 - Current
- Perform routine testing of finished products, raw materials, and stability samples
- Prepare reagents and solutions in accordance with standard operating procedures
- Assist with additional testing for R&D, OOS and deviation investigations
- Assist in OOS/Deviation investigation write ups
- Lead and assist with quality risk assessments
- Interface, populate, and maintain the LIMS system
- Provide timely and high-quality data and stability reports
- Generate purchase orders, schedule instrument calibrations, and maintain spreadsheets
- Analyze chemical compositions utilizing HPLC techniques
- Responsible for training ne QC Chemistry employees as needed
- Prepare and send samples to outside laboratories for testing when required
- Perform change controls independently, collaborating when needed
- Write laboratory OOS and deviations independently
Quality Control Microbiologist II
SPI Pharma
Grand Haven
06.2022 - 04.2025
- Prepare Microbiology media and solutions in accordance with standards operating procedures
- Perform routine testing of finished products, raw materials and stability samples
- Perform Microbial swab sampling for routine cleaning and validations
- Write controlled documents, such as stability reports, test procedures and standard operating procedures
- Interface, populate, and maintain the LIMS system
- Composite finished products for microbial/chemical testing
- Assist with additional testing for R&D, OOS and deviation investigations
- Train new QC Microbiology employees as needed
- Perform microbial method validations
- Perform change controls independently, collaborating when needed
- Write laboratory OOS and deviations independently
Education
Bachelor of Science - Biology
University of Wisconsin, Oshkosh
Oshkosh, Wisconsin, WI05-2021
Skills
- cGMP/GLP
- Data integrity
- OOS investigations
- Test method/SOP authoring
- Report writing
- Audit readiness
- Method validation
- LIMS/Empower
- Stability testing
- Resource allocation
- Change control
- Critical thinking
- Risk assessments
- Technical report writing
- Project management
Timeline
Quality Control Chemist I
SPI Pharma
04.2025 - Current
Quality Control Microbiologist II
SPI Pharma
06.2022 - 04.2025
Bachelor of Science - Biology
University of Wisconsin, Oshkosh