Sansika Sivanantham
Riverside,CA
Summary
Experienced Quality Control professional with over 10 years of hands-on expertise in analytical testing, regulatory compliance, laboratory operations, and team leadership. Proven track record in method development, process improvement, strategic planning, and quality assurance within highly regulated environments. Skilled in cross-functional collaboration and mentoring teams to exceed performance goals.
Overview
15
15
years of professional experience
Work History
Quality Control Supervisor
Grifols Biologicals LLC
Los Angeles, CA
06.2022 - Current
- Lead investigations into OOS results and perform root-cause analysis
- Review OOS checklists with analysts and recommend corrective/preventive actions
- Assign and manage daily tasks to ensure timely test execution and review
- Review and approve test results in SAP, ensuring accuracy and compliance
- Oversee final container, stability, and validation testing and ensure reagent inventory
- Manage lab workflow, prioritize tasks, and support Chemists with troubleshooting
- Train new analysts and provide technical guidance on analytical procedures
- Maintain proper documentation (IMF, stability binders, logbooks, etc.)
Senior Chemist
Grifols Biologicals LLC
07.2021 - 06.2022
- Supervised In-Process Lab during Supervisor absences
- Performed product release, stability, and in-process testing
- Reviewed and approved results in LIMS and initiated OOS investigations
- Tracked data for trending and supported various departmental projects
- Assisted in training and mentoring new analysts
- Managed equipment maintenance, calibration, and supply inventory
QC Chemist II
Grifols Biologicals LLC
08.2019 - 07.2021
- Conducted peer review of test results
- Executed QC testing and ensured proper documentation in LIMS
- Maintained instrument logs, calibration, and compliance with FDA regulations
QC Chemist I
Grifols Biologicals LLC
03.2018 - 08.2019
- Performed QC tests including product release, stability, and in-process testing
- Maintained sample logs and performed instrument calibration
- Ensured documentation accuracy per FDA and company procedures
Department Manager – Organics Extraction, GC Extraction, Glassware
Eurofins Eaton Analytical
Monrovia, CA
02.2017 - 03.2018
- Led teams and ensured SOP compliance and documentation
- Oversaw training and technical development for analysts
- Coordinated with QA and Client Services to resolve quality issues
- Implemented Lean and 5S principles to streamline operations
- Supported method development (UCMR4 525.3 & 546 ELISA)
Scientist I – GC Department
Eurofins Eaton Analytical
01.2016 - 02.2017
- Performed routine GC analysis on water samples per EPA methods
- Conducted QC review and instrument maintenance
- Managed documentation and data entry
Scientist I – Extraction Department
Eurofins Eaton Analytical
04.2014 - 12.2015
- Prepared water samples per EPA methods
- Contributed to method development (UCMR4 544)
- Maintained accurate documentation and records
Laboratory Assistant
Specialty Enzymes and Biochemicals Co.
Chino, CA
03.2014 - 04.2014
- Conducted ID tests on raw materials (FTIR, pH, LOD, etc.)
- Handled sample preparation and document control
- Communicated with suppliers and maintained inventory systems
Quality Assurance Assistant
11.2013 - 02.2014
- Filed and organized QA documents
- Prepared certificates of analysis and coordinated external testing
Laboratory Assistant
University of California, Riverside
Riverside, CA
06.2010 - 09.2010
- Prepared chemical reagents and managed lab inventories
- Provided support to lab users and faculty
- Trained and supervised new assistants
Education
Bachelor of Science - Chemistry
University of California, Riverside
Riverside, CA06.2013
Skills
- Analytical Instruments: GC, FTIR, ELISA, EPA Methods, FDA-regulated methods
- Software: SAP, LIMS, Microsoft Office Suite (Word, Excel, PowerPoint)
- Core Skills: SOP development, CAPA, root cause analysis, documentation control, team training
- Professional Traits: Detail-oriented and well-organized
- Strong communicator and team collaborator
- Proactive, reliable, and committed to continuous improvement
Timeline
Quality Control Supervisor
Grifols Biologicals LLC
06.2022 - Current
Senior Chemist
Grifols Biologicals LLC
07.2021 - 06.2022
QC Chemist II
Grifols Biologicals LLC
08.2019 - 07.2021
QC Chemist I
Grifols Biologicals LLC
03.2018 - 08.2019
Department Manager – Organics Extraction, GC Extraction, Glassware
Eurofins Eaton Analytical
02.2017 - 03.2018
Scientist I – GC Department
Eurofins Eaton Analytical
01.2016 - 02.2017
Scientist I – Extraction Department
Eurofins Eaton Analytical
04.2014 - 12.2015
Laboratory Assistant
Specialty Enzymes and Biochemicals Co.
03.2014 - 04.2014
Quality Assurance Assistant
11.2013 - 02.2014
Laboratory Assistant
University of California, Riverside
06.2010 - 09.2010
Bachelor of Science - Chemistry
University of California, Riverside