Software QA mit JIRA
Kalyani Manoj Umtekar
BIOTECHNOLOGY RESEARCHER
Pune
Summary
Postgraduate Biotechnology researcher with expertise in enzyme-based biosensor development, molecular diagnostics, and quality-compliant laboratory operations. Experienced with PCR-based assays, Bio-Rad D-10 instrumentation, and BSL-2 biosafety protocols under NABL/ISO 15189 standards. Trained in CRISPR genome editing, bioinformatics tools, and software quality assurance. Seeking a PhD position to advance research at the interface of nanobiotechnology and point-of-care diagnostics.
Overview
4
4
Languages
6
6
Certifications
1
1
year of professional experience
Work History
Laboratory Analyst & QA Trainee
Persistent Systems × Bio-Rad
03.2026 - Current
- Operate Bio-Rad D-10 HPLC system for HbA1c and HbA2 quantification in clinical blood samples.
- Perform sample preparation, instrument calibration, QC checks, and troubleshooting according to GLP standards.
- Manage BSL-2 biosafety compliance; maintain audit-ready documentation and sample traceability logs.
- Author and implement Standard Operating Procedures (SOPs); coordinate reagent inventory and lab workflows.
- Software QA: author test cases, perform regression testing, and track defects via JIRA for Bio-Rad D-10 v5.01.
- Conducted routine laboratory tests, ensuring compliance with standard operating procedures and safety regulations.
- Assisted in the analysis of biological samples, contributing to accurate and timely results for research projects.
- Utilized advanced analytical techniques to document findings, enhancing laboratory data accuracy and reliability.
- Collaborated with cross-functional teams to streamline laboratory processes, improving efficiency and project turnaround times.
- Participated in quality assurance initiatives, supporting compliance with regulatory guidelines and best practices.
- Executed data entry and record-keeping tasks, fostering organized laboratory documentation and traceability.
- Contributed to the development of standard operating procedures, enhancing reproducibility and consistency across experiments.
- Conducted routine maintenance on laboratory equipment, ensuring optimal performance and minimizing downtime.
- Ensured proper handling of hazardous materials according to established guidelines for safe disposal or storage.
- Prepared samples and assisted laboratory personnel in performing qualitative and quantitative analysis using analytical instruments, techniques and methods.
- Maintained detailed records of all laboratory activities within a centralized database, promoting transparency and collaboration among team members.
- Interpreted complex data sets for clients, providing them with clear insights into their samples'' composition and quality.
- Assisted in ordering laboratory supplies and necessities to maintain appropriate level of inventory.
- Streamlined sample preparation processes, reducing turnaround time for analysis results.
- Improved laboratory efficiency by streamlining sample processing and implementing quality control measures.
- Implemented process improvements based on feedback from team members or clients to enhance service offerings continually.
- Collaborated with cross-functional teams to achieve project goals and increase overall productivity.
- Participated in research projects to advance scientific knowledge within the industry sector.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Prepared samples for analysis by performing complex sample preparation tasks.
- Supported development team in implementing effective QA methodologies throughout the project life cycle.
- Completed inspection reports, describing performance outcomes, and carefully documenting irregularities or variances from expected outcomes.
M.Sc. Dissertation Research
MIT World Peace University
07.2025 - 02.2026
- Developed enzyme-based electrochemical biosensor: β-lactamase conjugated with silver nanoparticles (AgNP) for detection of β-lactam antibiotics.
- Optimised analytical sensitivity, dynamic range, signal-to-noise ratio, and assay reproducibility.
- Applied UV-Vis spectrophotometry, nanoparticle characterisation, and enzyme kinetics; documented results for publication preparation.
- Conducted comprehensive literature reviews to synthesize findings in molecular diagnostics research.
- Developed experimental protocols for biosensor assays, enhancing data reliability and reproducibility.
- Collaborated with cross-functional teams to design and implement innovative research methodologies.
- Utilized advanced laboratory techniques, including PCR and ELISA, to analyze biological samples.
- Worked well in a team setting, providing support and guidance.
Intern - Molecular Diagnostics
Millennium Special Pathology Lab
06.2025 - 07.2025
- Performed PCR and RT-PCR assays for SARS-CoV-2, Dengue, Influenza, Zika, and Chikungunya.
- Interpreted clinical results for patient sample validation per approved SOPs under BSL-2 conditions.
- Supported audit-ready documentation and identified workflow steps critical for minimising diagnostic errors.
- Assisted in the preparation and analysis of molecular diagnostic samples, ensuring accuracy and reliability.
- Conducted routine quality control checks on laboratory equipment, maintaining compliance with safety standards.
- Performed data entry and documentation for test results, streamlining reporting processes and enhancing efficiency.
- Collaborated with team members to troubleshoot technical issues, improving laboratory workflow and productivity.
Education
M.Sc. Biotechnology - Molecular Diagnostics & Biosensor Research
MIT World Peace University (MIT-WPU)
Pune, India06-2026
B.Sc. Microbiology -
Fergusson College (Autonomous)
Pune06-2024
Higher Secondary Certificate (HSC) - Science Stream
Fergusson College
Pune06-2021
Skills
Biosensor Development (AgNP)
PCR
RT-PCR
qPCR
DNA / RNA Extraction
CRISPR-Cas9 Gene Editing
Bio-Rad D-10 HPLC Operation
UV-Vis Spectrophotometry
Enzyme Kinetics & Assays
Molecular Cloning & Primer Design
SOP Writing
GLP
GMP
NABL
ISO 15189 Standards
AutoDock
PyRx
BLAST
NGS Concepts & Data Analysis
Software QA
JIRA (Basic)
HPLC operation
Sample preparation
GLP compliance
BSL-2 biosafety
Quality control checks
Data entry
PCR and RT-PCR
Molecular diagnostics
Software
R LANGUAGE, PYTHON
Certification
Merck: CRISPR Genome Editing
Personal data processing
I hereby confirm that the information provided is accurate and complete.
Timeline
Laboratory Analyst & QA Trainee
Persistent Systems × Bio-Rad
03.2026 - Current
M.Sc. Dissertation Research
MIT World Peace University
07.2025 - 02.2026
Intern - Molecular Diagnostics
Millennium Special Pathology Lab
06.2025 - 07.2025
M.Sc. Biotechnology - Molecular Diagnostics & Biosensor Research
MIT World Peace University (MIT-WPU)
B.Sc. Microbiology -
Fergusson College (Autonomous)
Higher Secondary Certificate (HSC) - Science Stream
Fergusson College