Srushtiben Patel
Atascadero,CA
Summary
Detail-oriented laboratory technician and quality control microbiologist dedicated to ensuring product safety and compliance within GMP-regulated environments. Expertise in sterility testing, environmental monitoring, and SOP development enhances contamination control and inspection readiness. Proven track record of supporting internal audits and maintaining meticulous documentation for regulatory standards.
Overview
8
8
years of professional experience
Work History
Quality Control Microbiologist
ShanPar Industries Private Ltd.
Gujarat, India
01.2023 - 03.2023
- Executed microbiological testing of raw materials, in-process samples, and finished dietary supplement products per USP 61 and USP 62, ensuring compliance with regulatory standards.
- Monitored and tested Purified Water systems per USP 1231 Water for Pharmaceutical Purposes, ensuring microbial limits met regulatory and internal specifications.
- Performed environmental monitoring (viable air, surface, and personnel monitoring) in controlled manufacturing areas, supporting contamination control and GMP compliance.
- Prepared, sterilized, and qualified culture media, including growth promotion testing (GPT), to support routine QC microbiology testing.
- Maintained microbial cultures, reference organisms, and positive controls in compliance with cGMP documentation and traceability requirements.
- Authored, revised, implemented SOPs, test methods, logbooks, and controlled forms, improving procedural consistency and inspection readiness.
- Investigated microbial deviations and OOS results, conducted root cause analysis, and facilitated CAPA implementation to enhance quality systems.
- Supported internal audits and regulatory inspections by maintaining complete, accurate, and contemporaneous GMP documentation.
- (Dietary Supplements | FDA / GMP Compliant)
Research and Development
Gujarat Vidyapith
Gujarat, India
11.2015 - 08.2021
- Designed and executed microbiological experiments, generating reproducible data to support research and development objectives.
- Performed microbial assays, molecular techniques (SDS PAGE and Protein Purification), and method validation and optimization to improve assay performance and reliability.
- Maintained and monitored microbial cultures and cell lines to support research initiatives and product development.
- Prepared and qualified media, buffers, and reagents using aseptic techniques, ensuring integrity of microbiological experiments.
- Documented, analyzed, and trended experimental data per laboratory protocols, enhancing data integrity and reliability.
- Supported laboratory operations by maintaining instrumentation calibration, functionality, and compliance with established procedures.
- (Microbiology / Product Development)
Quality Control Microbiologist
Sahajanand Laser Technology Ltd.
Gujarat, India
06.2015 - 08.2015
- Performed sterility testing of finished medical device products in compliance with USP 71 Sterility Tests, supporting consistent batch release and regulatory compliance.
- Isolated and identified microorganisms from products, water, and environmental samples using biochemical and cultural techniques to ensure product safety and compliance.
- Monitored and evaluated Purified Water (PW) and Water for Injection (WFI) systems per USP 1231, ensuring microbiological control and trending.
- Conducted routine cleanroom environmental monitoring (viable air, surface, and personnel) in classified areas per ISO 14644 and internal contamination control strategies.
- Maintained and qualified microbial cultures, reference strains, and positive controls to support routine and investigative testing.
- Investigated OOS, OOT, and atypical results and conducted deviation investigations to support CAPA efforts and drive continuous improvement.
- Performed routine calibration, verification, and maintenance of microbiology laboratory equipment, ensuring data integrity and GMP compliance.
- Maintained GDP- and GMP-compliant documentation to facilitate internal audits, supplier audits, and FDA inspections, ensuring regulatory adherence.
- (Medical Devices | GMP Environment)
Education
Doctorate in Philosphy - MICROBIOLOGY
Gujarat University
Gujarat, India02-2022
MASTER OF SCIENCE - MICROBIOLOGY
Gujarat University
Gujarat, India04-2013
BACHELOR OF SCIENCE - MICROBIOLOGY
Sardar Patel University
Gujarat, India04-2011
Skills
- Sterility Testing
- Environmental Monitoring
- Water Testing
- Cleanroom Control
- Contamination Control
- Aseptic Techniques
- Growth Promotion
- Media Preparation
- SOP Development
- Documentation
- Deviation Investigations
- CAPA
- Equipment Calibration
- Lab Maintenance
- BET (LAL)
Timeline
Quality Control Microbiologist
ShanPar Industries Private Ltd.
01.2023 - 03.2023
Research and Development
Gujarat Vidyapith
11.2015 - 08.2021
Quality Control Microbiologist
Sahajanand Laser Technology Ltd.
06.2015 - 08.2015
Doctorate in Philosphy - MICROBIOLOGY
Gujarat University
MASTER OF SCIENCE - MICROBIOLOGY
Gujarat University
BACHELOR OF SCIENCE - MICROBIOLOGY
Sardar Patel University