Anish Patel
Elgin,IL
Summary
Quality-focused professional with expertise in quality control, regulatory compliance, and process optimization seeking a role in a pharmaceutical and/or medical device company. Committed to ensuring product quality, safety, and adherence to industry standards while driving continuous improvement initiatives.
Overview
12
12
years of professional experience
Work History
Scientist II
FRESENIUS KABI
11.2022 - Current
- Collaborate with operations and Quality Assurance in conducting root cause investigations for deviations, OOS, OOL, environmental events, and protocols using Trackwise System
- Review/Technical Review and template documents regarding ALCOA+
- Mitigate risks to prevent deviations and create CAPA to prevent future occurrence
- Perform instructor led training for new and current employees
- Perform routine testing on finished product, raw materials, and stability samples
- Conduct testing such as Sterility, Kinetic Turbidimetric Assay (KTA), Gel-Clot LAL Assay, Pre-filtration Bioburden (PFBB), Pre-sterilization Bioburden (PSB)
- Critical Systems Releases
- Support FDA regulation audit review/response (21 CFR 820, 21 CFR 210/211)
- Revise and update procedures within SOPs using Documentum
- Enter data/Review/Approve using LIMS (Laboratory Information Management System).
Scientist I
FRESENIUS KABI
10.2021 - 11.2022
Associate Scientist
FRESENIUS KABI
08.2017 - 10.2021
- Support production by performing Environment Monitoring within cleanroom ISO5, ISO7, and ISO8 areas within the facility
- Perform non-viable airborne particulate, viable airborne bioburden, viable surface bioburden, settle plate bioburden, and personnel monitoring
- Collect and test samples from water for injection (WFI) ports, clean steam, and compressed gases
- Perform Water for Injection bioburden (WFIBB), Endotoxin, and Total Organic Carbon (TOC)
- Process paperwork to help support with critical systems release of department
- Maintain laboratory areas 5S quality, follow aseptic, and safety procedures within all areas
- Perform growth promotion on incoming media and solutions used for environmental monitoring/testing
- Input results using Laboratory Information Management System (LIMS) database.
Sales
SKY TELECOMMUNICATIONS OF ORLANDO, FL
06.2012 - 08.2017
- Assisted company executives with defining new sales channels to increase revenue
- Performed bookkeeping tasks by issuing new invoices, calculating month-end reconciliations
- Interacted with regional clients to support and enhance customer service.
Research Assistant
SOUTHERN ILLINOIS UNIVERSITY OF EDWARDSVILLE
01.2013 - 12.2015
- Conducted chemical reactions under fume hood with a team of five students
- Documented importance of all instruments used to include those of chemistry and microbiology
- Performed basic chemistry, microbiology, and biology techniques using various methodologies.
Education
Bachelor of Science - Integrative Biology
Southern Illinois University of Edwardsville, College of Arts and Sciences
05.2016
Skills
- Project Planning
- Oral/Written Communications
- Creative Problem Solving
- Teamwork
- Attention to details
- Leadership
- Troubleshooting
Languages
English
Full Professional
Spanish
Limited
Gujarati
Native/ Bilingual
Timeline
Scientist II
FRESENIUS KABI
11.2022 - Current
Scientist I
FRESENIUS KABI
10.2021 - 11.2022
Associate Scientist
FRESENIUS KABI
08.2017 - 10.2021
Research Assistant
SOUTHERN ILLINOIS UNIVERSITY OF EDWARDSVILLE
01.2013 - 12.2015
Sales
SKY TELECOMMUNICATIONS OF ORLANDO, FL
06.2012 - 08.2017
Bachelor of Science - Integrative Biology
Southern Illinois University of Edwardsville, College of Arts and Sciences