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Venkata Sai Nithin Reddy Yendapalli

QA Technician • Phoenix, AZ • n*********@gmail.com • +19******678 • linkedin/•••••

Professional Summary

QA Technician with 2+ years supporting GMP quality assurance and laboratory-facing testing within regulated pharmaceutical manufacturing. Experienced in batch and master batch record review, deviation investigations, CAPA and root cause analysis, and SAP/MES-supported inventory and documentation workflows. Skilled with Veeva Vault, Infinity QMS, LIMS, Syncade and DeltaV to manage quality events, improve review turnaround, and strengthen audit readiness. Seeking to contribute reliable GMP oversight, structured investigations, and process improvements to a QA/operations team in pharmaceutical manufacturing.

Technical Skills

Testing: Veeva Vault,Infinity QMS,CAPA,Deviation Management,Root Cause Analysis,Master Batch Record Review,Batch Disposition,SOP Authoring and Revision,Labeling Controls,Material Qualification,ALCOA+ Data Integrity
Tools and Methodologies: MS Office Suite
Manufacturing & Production Systems: MES,Syncade,SAP,DeltaV,LIMS
Regulatory & Standards: 21 CFR Part 210,21 CFR Part 211,cGMP,Audit Readiness,Risk-Based Decision Making

Work Experience

Bristol Myers Squibb
Devens, MA
Senior QA Operations Field Specialist
Mar 2023 – Jan 2026
Tech Stack: GMP, GxP, Master Batch Records, SOPs, Root Cause Analysis, CAPA, Veeva Vault, SAP, MES, Syncade, DeltaV, LIMS, Infinity QMS, MS Office Suite
  • Directed GMP oversight across single-use and large-scale cell culture operations, performing organoleptic and analytical in-process checks using DeltaV and LIMS to validate critical parameters and support QA/QC for clinical and commercial-scale batches.
  • Reviewed Master Batch Records, batch records, SOPs and labels in Veeva Vault and SAP to support batch disposition and product release; identified documentation gaps and prevented potential non-conforming shipments.
  • Led deviation investigations and batch impact assessments using Infinity QMS and formal root cause analysis techniques; documented CAPAs and corrective actions to strengthen non-conformance handling and reduce recurrence risk.
  • Managed quality-event workflows and SAP-supported inventory movements, coordinating retained sample control and MES record keeping to streamline documentation processes and improve traceability.
  • Partnered with Manufacturing, Engineering, Quality and Regulatory teams to perform GMP walkthroughs and in-line compliance checks; recommended process and labeling improvements that enhanced audit readiness and operational consistency.
  • Trained and onboarded 5 new QA hires on logbooks, MBR review, labeling controls and GMP walkthrough protocols; developed checklists and training aids to reinforce execution discipline and reduce onboarding time.

Education

Wright State University
Master of Science in Pharmacology and Toxicology • Ohio, USA • Aug 2021 – Dec 2022
Raghavendra Institute of Pharmaceutical Education and Research
Bachelor of Pharmacy • Andhra Pradesh, India • Jun 2016 – Aug 2020

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