Quality Control Regulatory Compliance

Nagendra Babu Bommupalla

**********************@*****.*** linkedin://nagendrababu New Haven, CT, USA

Detail-oriented QC Analyst with 2 years of experience in pharmaceutical quality control, specializing in analytical instrumentation and regulatory compliance. Proven track record in performing HPLC, GC, and Mass Spectrometry (MS) analyses to ensure product integrity and consistency. Adept at following strict Standard Operating Procedures (SOPs) and maintaining documentation in compliance with Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP). Demonstrates strong analytical thinking, meticulous attention to detail, and expertise in ELISA for bioanalytical assessments.

EXPERIENCE

Aurobindo Pharma 06/2022 – 6/2023

Quality Control Lab Analyst Hyderabad, India

Performed routine and non-routine testing of pharmaceutical raw materials, intermediates, and finished products using HPLC, GC, and MS by SOPs and validated methods.

Conducted qualitative and quantitative analysis of pharmaceutical samples, ensuring strict compliance with cGMP guidelines.

Maintained and calibrated laboratory instruments, including HPLC, GC, and balances, adhering to scheduled preventive maintenance.

Prepared and reviewed technical documents such as COAs, test protocols, and deviation reports following GDP standards.

Participated in ELISA testing for biologic drug components, ensuring accurate detection and quantification of analytes.

Executed stability testing programs for drug substances and products to monitor degradation and shelf-life performance.

Coordinated with the QA department to address OOS (Out-of-Specification) results, CAPA implementation, and audit readiness.

Monitored environmental conditions and performed cleaning verification to maintain regulatory compliance within lab settings.

Trained new staff in lab safety, SOP adherence, and proper documentation by GDP requirements.

Supported internal and external audits, providing documentation and clarification related to QC, cGMP, and instrumentation.

Aurobindo Pharma 06/2021 – 11/2021

Quality Control Lab Analyst Intern Hyderabad, India

Assisted in conducting sample analysis using HPLC, GC, and UV spectrophotometry under supervision, following defined SOPs.

Gained hands-on experience in preparing mobile phases, standards, and reagents required for chromatographic analysis.

Participated in the documentation of analytical procedures and results in compliance with GDP and laboratory practices.

Observed routine cGMP protocols in the quality control lab, including gowning, documentation, and record maintenance.

Shadowed senior analysts during ELISA procedures and developed familiarity with plate reading and sample preparation techniques.

Supported the calibration and verification of analytical instruments, contributing to consistent and reliable data outputs.

Assisted with sample collection, labeling, and storage following cGMP protocols to ensure traceability and integrity.

Logged and tracked lab consumables, maintaining inventory to ensure uninterrupted analytical workflows.

Maintained cleaning records and participated in routine instrument and workspace sanitization in compliance with SOPs.

Prepared detailed reports on training activities and analytical procedures for supervisor review and feedback.

PROJECTS

Dynamic Mechanical Analysis of – University of New Haven 08/2024 – 12/2024

Performed Dynamic Mechanical Analysis (DMA) on pharmaceutical-grade polymers to assess viscoelastic behavior, supporting packaging and stability studies under SOP-driven protocols.

Analyzed and interpreted polymer thermal transitions and modulus values, documenting observations in line with GDP and regulatory standards.

Conducted Environmental Monitoring in cleanroom areas using settle plates, air samplers, and surface swabs, ensuring microbial control per cGMP guidelines.

Maintained accurate records for both mechanical and microbial analyses, ensuring traceability and audit readiness through strict adherence to GDP.

Collaborated with the quality team to identify trends, support CAPA investigations, and implement improvements aligned with SOPs and cGMP standards.

SKILLS

Analytical Techniques: HPLC, GC, MS, ELISA, UV-Vis Spectroscopy, Dissolution Testing, Titration

Regulatory & Quality Compliance: cGMP, GDP, SOPs, Data Integrity, Deviation Management, Change Control

Tools: Empower 3, LabSolutions, ChemStation, LIMS, Microsoft Excel, SAP QM Module

Documentation & Reporting: Analytical Method Validation, Certificate of Analysis (COA), Calibration Records, Logbooks

EDUCATION

University of New Haven MS in Chemistry 3.17/4.0 08/2023 – 12/2024

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