Nilambari Pawar
Olathe,KS
Summary
Dynamic Quality Assurance and Quality Control Specialist with over 9 years of experience in the pharmaceutical industry, demonstrating extensive expertise in qualitative and quantitative analysis techniques. A solid foundation in scientific principles, analytical methods, and biological and physical chemistry enhances the ability to ensure compliance and drive quality improvements. Recognized for exceptional dedication to customer service and a patient-first approach, along with receiving Achievement Awards for contributions to quality enhancement initiatives. Proven track record of collaborating with cross-functional teams to foster a culture of excellence and continuous improvement in quality standards.
Overview
1
1
Certification
10
10
years of professional experience
Work History
Specialist-Quality Assurance & Quality Control
Catalent Pharma Solutions
Kansas City, MO
01.2023 - Current
- Conducted thorough inspections and worked alongside quality team to establish and execute corrective measures.
- Reviewed and approved certificates of analysis and analytical result forms.
- Conducted thorough audits of stability and technical reports to maintain compliance standards. Oversaw approval of analytical methods specifications and protocols to ensure accuracy and reliability.
- Audit Method validation and method transfers.
- Revised Standard operating procedures (SOPs) in compliance with FDA guidelines, regulations, GxPs.
- Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
Senior Associate Scientist II
Catalent Pharma Solutions
Kansas City, MO
03.2021 - 01.2023
- In support of large molecule therapeutics, execute laboratory work include in-process, release or stability.
- Techniques used such as: HPLC/UHPLC techniques/methods, KF & protein concentration, perform Compendia assays.
- Responsible for performing method validation or transfer activities and to perform activities under cGMP.
- To draft compliance document and for regulatory compliance review/audit protocols, specifications, methods, validated spreadsheets, reports, lab documentation.
- Train, guide, and mentor new or junior scientists on client methods.
Associate Scientist
Catalent Pharma Solutions
Kansas City, MO
05.2017 - 03.2021
- In support of small molecules analytical chemistry, conducted experiments in laboratory environment for product development purposes in GMP environment.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Attend client conference call.
- Performed Lab audits and review of lab documentations.
Research Intern
University Of Kansas
Lawrence, KS
01.2016 - 03.2016
- Completed research, compiled data, updated spreadsheets, and produced timely reports.
- Assisted scientists by collecting and organizing laboratory data.
- Set and oversaw quality assurance guidelines for laboratory work.
- Trained and supervised junior technicians in laboratory protocols.
Education
Master of Science - Biotechnology
University of Mumbai
Mumbai. India06-2012
Bachelor of Science - Biotechnology
Shivaji University
Kolhapur, India04-2010
Skills
- Internal Audits
- Quality Assurance/ Quality Control
- Technical Documentations
- Method validatons
- Audit Reports, Validation protocols
- Empower, Openlab- Citix data analysis
- Customer Satisfaction
- Quality Continuous Improvement
- Safety Procedures
- Project Management
- FDA Compliance
- Laboratory Equipment Functions
- Document Control & Management System (EDMS)
- Cross-Collaboration
- Trackwise/Pathwise
Certification
Project Management: The Basics for Success, UCI
Timeline
Specialist-Quality Assurance & Quality Control
Catalent Pharma Solutions
01.2023 - Current
Senior Associate Scientist II
Catalent Pharma Solutions
03.2021 - 01.2023
Associate Scientist
Catalent Pharma Solutions
05.2017 - 03.2021
Research Intern
University Of Kansas
01.2016 - 03.2016
Master of Science - Biotechnology
University of Mumbai
Bachelor of Science - Biotechnology
Shivaji University