Quality Assurance Specialist

SUPRIYA SADINENI

Email: ********.**@*****.*** Phone: +1-409-***-**** LinkedIn: https://www.linkedin.com/in/supriya-864930263?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app Location: Morrisville, NC

PROFESSIONAL SUMMARY

Quality Assurance Specialist with 3+ years of experience in deviation investigation, compliance, validation, and documentation within regulated environments (FDA, ISO, ICH). Proven expertise in root cause analysis, CAPA, GMP auditing, and equipment validation. Proficient with MasterControl, Veeva, LIMS, and industry-standard analytical instruments. Adept at streamlining processes, enhancing compliance, and collaborating cross-functionally to drive quality improvements.

CORE COMPETENCIES

Deviation Investigation CAPA SOP Writing GMP Compliance Equipment Validation Cleaning Validation Root Cause Analysis (5 Whys, Fishbone, FMEA) MasterControl Veeva LIMS EDMS HPLC GC UV-VIS FDA 21 CFR ISO 13485 ICH-GCP

PROFESSIONAL EXPERIENCE

Azzur Group LLC, Consultant Nov 2023 – Present

- Supported deviation investigations and CAPA development for pharmaceutical clients.

- Assisted in audit preparation and maintained compliance documentation in MasterControl.

FUJIFILM Diosynth Biotechnologies, QA Specialist (via Azzur Group)

Dec 2024 – Present

Led investigations for GMP deviations and implemented CAPAs in compliance with FDA 21 CFR and ISO 13485.

Authored SOPs and performed risk assessments for new processes and cleaning verification (5 PV lots).

Managed controlled documents via MasterControl and Veeva; ensured audit-readiness.

Contributed to successful regulatory inspections with zero critical observations.

National Resilience, Deviation Investigator ((via Azzur Group)

Nov 2023 – Dec 2024

Conducted detailed root cause analyses and tracked deviation lifecycle using MasterControl.

Reduced deviation closure time by 20% through process streamlining and personnel training.

Delivered GMP compliance training sessions to cross-functional teams.

Created dashboards to present deviation and CAPA metrics to senior leadership.

DIVI’S Laboratories, Vizag, India, Quality Analyst May 2021 – Dec 2021

Conducted analytical testing and cleaning validation in a cGMP-compliant environment.

Authored and reviewed validation protocols and SOPs for HPLC, GC, and UV-VIS instruments.

Supported method development and ensured quality documentation was audit ready.

EDUCATION

M.S., Chemical Engineering

Lamar University, Texas

Jan 2022 – Aug 2023 GPA: 3.52

Relevant Courses: Kinetics, Sustainability, Process Simulation, Engineering Management

B.Tech, Chemical Engineering

RVR&JC College of Engineering, India

Aug 2017 – Apr 2021 GPA: 3.75

Relevant Courses: Mass/Heat Transfer, Reaction Engineering, Process Optimization

CERTIFICATIONS

Lean Six sigma -white belt, March 2024

CAPA Training – Internal training program, Dec 2023

GMP Compliance Training-Internal training Program, Jan 2024

TECHNICAL SKILLS

Software: MasterControl, Veeva, LIMS, EDMS

Instruments: HPLC, GC, UV-VIS, pH Meters, Autoclaves

Standards & Regulations: FDA 21 CFR 210, 211, 820; ISO 13485; ICH-GCP

Methodologies: 5 Whys, Fishbone Diagram, FMEA, CAPA, Risk Assessment

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