James F. Bird
Fullerton
Overview
18
18
years of professional experience
Work History
Quality Specialist (Microbiology)
Matrix Sciences
12.2020 - 05.2023
- Validation/protocol writing and revision
- Method verification testing
- Document/ lab results review and approval
- SOP revision and corrections
- Facility Audit Support
- Incident investigation/reports CAPAs
- Equipment maintenance and calibration
Senior Microbiologist
Nitto Avecia Pharma Services
04.2013 - 09.2019
- Microbiology testing according to USP/EP guidelines in eGLP environment
- Sterility, Endotoxin, Bioburden, Biological Indicator, Population Verification, and Growth Promotion Testing
- Internal and FDA Auditing
- Validation writing and testing for all methods
Senior QC Microbiology Technician
Gilead Sciences
06.2009 - 04.2013
- Qualification and Recertification of production and aseptic areas in a cGMP facility
- Environmental monitoring of manufacturing and aseptic production areas and Product Fill support (ISO 5 Level 1 Gown Qualified)
- WFI/RO/Pure Steam sampling, gas port testing, equipment sterilization and validation support for new aseptic fill line for lyophilized product
R&D Technician (Contract)
Irvine Scientific
02.2008 - 07.2008
- Research of cell culture media to increase and optimize cell growth for protein production
- Media production, daily cell counts, cell passaging and equipment sterilization
Microbiologist
Certified Laboratories
11.2006 - 02.2008
- Media testing of processed and environmental samples for bacterial contamination
- PCR, ELISA, Food/Environmental sample prep and plating, selective media transfer, media production and plate count
Microbiology Technician (Contract)
Silliker, California Laboratory
05.2005 - 09.2006
- Sample processing and Log-in
- Food/Environmental sample prep and plating, media production and plate count
Education
Bachelor of Science - Biology
California State University, Fullerton
01.2003
Skills
- QC Testing
- Data Analysis
- Documentation Control
- Root Cause Analysis
- Audits
Timeline
Quality Specialist (Microbiology)
Matrix Sciences
12.2020 - 05.2023
Senior Microbiologist
Nitto Avecia Pharma Services
04.2013 - 09.2019
Senior QC Microbiology Technician
Gilead Sciences
06.2009 - 04.2013
R&D Technician (Contract)
Irvine Scientific
02.2008 - 07.2008
Microbiologist
Certified Laboratories
11.2006 - 02.2008
Microbiology Technician (Contract)
Silliker, California Laboratory
05.2005 - 09.2006
Bachelor of Science - Biology
California State University, Fullerton