Quality Assurance Associate GLP/gCGP Compliance

Shalini Dusari

Brunswick, MD 336-***-**** *******.******@*****.*** linkedin.com/in/shalini-dusari

Associate Scientist

Specialized experience in biologics, cell therapy manufacturing, and molecular biology research within GLP and cGMP environments. Detail-oriented Quality Assurance professional with hands-on experience supporting GLP and cGMP-regulated laboratories and manufacturing operations. Demonstrated expertise in FDA and EPA GLP compliance, internal audits, facility and process inspections, QA reporting, and electronic data integrity systems. Proven ability to support Sponsor and regulatory inspections, maintain audit readiness, and ensure compliance with SOPs, protocols, and global regulatory requirements while collaborating cross-functionally across Quality, Manufacturing, and Scientific teams.

Technical Skills

FDA & EPA GLP Compliance cGMP Regulations

Internal Audits, Facility & Process Inspections

QA Audit Reports & Quality Assurance Statements

SOP, Protocol & Data Review

Master Schedule (GLP) Management

Sponsor & Regulatory Inspection Support (FDA)

Electronic Data Integrity 21 CFR Part 11

LIMS, BRIQS, Oracle ERP, CTMS, eTMF

Deviations, Investigations & CAPAs

Batch Production Records (BPR) Review RFT

Sterility, Endotoxin (LAL), Bioburden Testing

Aseptic Processing & Cleanroom Operations

Vendor & Subcontractor Audits

Quality Training & Regulatory Support

Hands on Chromatography techniques(HPLC, Gas Chromatography etc)

Professional Experience

Millipore Sigma (Merck KGaA) Rockville, MD 4/2024 – 8/2025

Associate Scientist/Quality and Compliance Support

Applied working knowledge of “FDA and EPA GLP regulations” and applicable international guidelines to ensure laboratory and study compliance.

Conducted “internal audits, process inspections, and facility walkthroughs”, including review of protocols, SOPs, raw data, study reports, and direct observation of laboratory and manufacturing activities.

Prepared and issued “QA audit reports and quality assurance statements” for inclusion in final study reports; communicated findings to Study Directors, Principal Investigators, and management.

Maintained and updated the “GLP Master Schedule”, ensuring accuracy and compliance with regulatory requirements.

Supported “Sponsor, client, and regulatory inspections”, providing documentation, audit responses, and on-site QA support.

Served as a regulatory resource during “study initiation meetings” and cross-functional discussions.

Delivered “quality and compliance training” to new hires and laboratory personnel.

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Supported “GLP and cGMP-regulated laboratory operations” through execution of validated biosafety and quality control assays, including “sterility, endotoxin, bioburden, and viral clearance testing.

Applied advanced “aseptic techniques and sterile processing practices” in ISO-classified cleanrooms to support contamination control and inspection readiness.

Reviewed laboratory records, test results, and supporting documentation to ensure compliance with “SOPs, protocols, and regulatory requirements”.

Maintained accurate documentation and traceability using “LIMS-based systems”, supporting data integrity and audit readiness.

Manufacturing & Documentation Support

Documented laboratory assays, manufacturing activities, deviations, and investigations using “LIMS, BRIQS, and Oracle ERP”, maintaining audit readiness and data integrity.

Reviewed and approved “Batch Production Records (BPRs)” with a focus on “Right First Time (RFT)” execution.

Collaborated cross-functionally with “Manufacturing, MS&T, Process Development, QA/QC, and scientific SMEs to support technology transfer, method optimization, and continuous process improvement.

Participated in “vendor and subcontractor evaluations”, ensuring compliance with quality and regulatory standards.

Hood College Frederick, MD 8/2021 – 5/2023

Laboratory Research Assistant

Supported molecular biology research projects involving PCR, ELISA, and Western Blotting. Maintained compliance with GLP/cGMP documentation practices and ensured meticulous data integrity in research records. Generated detailed sample tracking reports and data analyses to support ongoing experiments.

Increased lab throughput 36% through method standardization, efficient inventory tracking, and scheduling optimization.

Elevated laboratory operations via collaboration with faculty and peers in SOP development and refinement.

Shantha Biotechnics Hyderabad, India 9/2011 – 9/2015

Analytical Research Intern

Performed routine and method-based analysis using High Performance Liquid Chromatography (HPLC) for assay determination, impurity profiling, and dissolution sample analysis of pharmaceutical formulations.

Conducted Gas Chromatography (GC) analysis for residual solvent testing and volatile compound identification in compliance with ICH guidelines.

Prepared mobile phases, calibration standards, and sample solutions following validated analytical procedures and SOPs.

Assisted in method development and optimization by adjusting flow rates, column selection, and detector parameters to improve resolution and sensitivity.

Performed system suitability testing and ensured instrument performance met predefined acceptance criteria.

Documented experimental data in laboratory notebooks and electronic systems in accordance with GLP/GMP documentation practices.

Supported troubleshooting of chromatographic issues such as peak tailing, baseline noise, and retention time shifts.

Conducted additional analytical techniques including:

UV-Visible Spectroscopy for quantitative estimation

FTIR spectroscopy for functional group identification

pH, dissolution, and stability studies

Participated in laboratory safety compliance and maintained instruments through routine calibration and preventive maintenance.

Assisted in data analysis and preparation of technical reports for research and regulatory submission purposes.

Globe Toters Hyderabad, India 1/2008 – 9/2011

Biology Instructor: Middle and High School

Delivered structured, engaging instruction in biology and human physiology, supporting understanding, motivation, and consistent learning behaviors among students.

Key Responsibilities:

Explained complex biological and health-related concepts in clear, relatable language.

Provided individualized guidance and encouragement to support progress, confidence, and accountability.

Reinforced routines, goal completion, and follow-through through regular feedback and structured assessments.

Fostered supportive, trust-based learning environments focused on growth and consistency.

Education

Master of Science (MS), Biomedical Sciences Hood College Frederick, MD 2023 3.85 GPA

Relevant Coursework

Molecular Immunology, Microbiology, Molecular Genetics, Protein Biochemistry, Bioinformatics, Medical Virology, Viral Epidemiology

Capstone Poster Presentation

Universal Influenza Vaccine Development: Proposed mRNA-based vaccine platform using IL15 as molecular adjuvant targeting HA stalk and conserved antigens to address annual flu strain variability.

Master of Science (MS), Pharmaceutical Sciences Jawaharlal Nehru Technological University India

Bachelor of Science (BS), Pharmacy Jawaharlal Nehru Technological University India

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