Ravikishore Mancheneni
QA SpecialistII
Redmond,WA
Summary
Dynamic Quality Assurance Specialist with a proven track record at Inventprise Inc., excelling in CAPA lifecycle management and process improvement. Adept at utilizing statistical tools to drive quality enhancements, while fostering cross-functional collaboration. Committed to maintaining inspection-ready documentation and delivering exceptional results in a cGMP environment.
Overview
7
7
years of professional experience
Work History
Quality Assurance Specialist II
Inventprise Inc.
Redmond, WA
06.2024 - 12.2025
- Developed, implemented, and maintained effective quality assurance controls supporting vaccine manufacturing operations in a cGMP environment, ensuring alignment with site QMS and corporate objectives.
- Owned the site CAPA program end-to-end, including governance, prioritization, escalation, effectiveness checks, and on-time closure, consistently maintaining >95% on-time CAPA closure.
- Led structured Root Cause Analysis using 5-Why, Fishbone, and 6M methods; defined robust corrective and preventive actions to eliminate recurrence and improve process capability.
- Coordinated identification, assignment, tracking, and completion of process and product improvement projects to address quality KPI trends, enhancing overall product quality.
- Reviewed and approved validation and verification protocols and reports (including method and equipment validation), and provided QA oversight for IQ/OQ/PQ and CQV activities.
- Partnered with Operations and Engineering to support pilot production, technology transfer, and scale-up activities, ensuring quality risk assessments, change control, and documentation were in place.
- Administered the site Change Control program, including impact assessments, risk analysis, and cross-functional approvals to ensure controlled implementation of process, equipment, and documentation changes.
- Generated and trended quality KPIs (deviations, CAPAs, complaints, and nonconformances) using statistical and quality tools to identify systemic issues, facilitating Lean and continuous improvement initiatives.
- Authored and technically reviewed SOPs, work instructions, and quality procedures to ensure they met QMS and regulatory expectations.
Quality Engineering Intern
Amneal Pharmaceuticals LLC
Branchburg, NJ
07.2023 - 08.2023
- Drafted and executed IQ/OQ validation protocols and authored final reports for packaging and manufacturing equipment, ensuring documented evidence of installation and operational qualification.
- Supported PQ activities and verified process performance through data collection, review, and documentation for commercial product runs, contributing to quality assurance.
- Applied statistical and quality tools (e.g., Minitab, Excel) to analyze process and test data, contributing to Root Cause Analysis and CAPA effectiveness verification.
- Reviewed SOPs, batch records, and validation documentation for accuracy and ALCOA+ compliance, ensuring alignment with quality and regulatory standards.
- Supported deviation investigations, CAPA documentation, and change control records for manufacturing and packaging operations in a regulated cGMP environment.
- Assisted with audit preparation by organizing documents and tracking CAPA commitments and due dates, facilitating compliance readiness.
Quality Assurance Associate Project Supervisor
Divi's Laboratories Ltd.
Hyderabad, India
12.2018 - 04.2021
- Led deviation investigations and full CAPA lifecycle management (initiation, root cause analysis, action definition, implementation, and effectiveness monitoring) for API manufacturing processes.
- Coordinated CQV and validation activities for process and equipment, reviewing IQ/OQ/PQ protocols, reports, and supporting data to ensure regulatory compliance.
- Managed site change controls, performing impact assessments on product quality, validation status, and regulatory commitments, and ensuring controlled implementation and closure.
- Provided QA oversight during material nonconformance evaluations, managing rejection, rework, and re-testing decisions while ensuring proper documentation and follow-up.
- Conducted risk assessments and contributed to the creation and revision of Control Plans and quality monitoring strategies for existing and new products.
- Conducted internal quality process and product audits, documented audit findings, and worked with owners to develop and implement responsive corrective action plans.
- Supported supplier qualification activities and quality appraisals through review of supplier documentation, questionnaires, and quality agreements, and feedback on supplier performance.
- Trained manufacturing, QC, and warehouse personnel on cGMP requirements and documentation practices, enhancing understanding of deviation and CAPA procedures.
- Participated as QA support during regulatory and customer audits, providing records, clarifications, and follow-up responses.
Education
Master of Science - Pharmaceutical Manufacturing Engineering
Stevens Institute of Technology
Hoboken, NJ01.2024
Bachelor of Technology - Mechanical Engineering
K L University
Guntur, India05-2017
Skills
- Quality Management Systems (QMS) implementation & maintenance
- Quality assurance controls
- Process and product quality monitoring
- Validation and verification
- CAPA lifecycle management
- Deviation investigations
- Change control
- Nonconformance management
- Internal audits
- Audit support
- SOPs
- Validation reports
- QMS documentation
- Data integrity
- Supplier quality
- Complaint management
- Batch record review
- Process improvement
- 5S
- Lean
- Six Sigma concepts
- FMEA
- Risk analysis
Additional Information
Eligible to support global regulatory and customer quality requirements, including EU-focused documentation (e.g., supplier surveys, EU MDR-related customer requests and declarations) as needed. Open to roles in Quality Assurance, Quality Engineering, and Operational Quality supporting implementation and continuous improvement of Quality Management Systems.
Timeline
Quality Assurance Specialist II
Inventprise Inc.
06.2024 - 12.2025
Quality Engineering Intern
Amneal Pharmaceuticals LLC
07.2023 - 08.2023
Quality Assurance Associate Project Supervisor
Divi's Laboratories Ltd.
12.2018 - 04.2021
Master of Science - Pharmaceutical Manufacturing Engineering
Stevens Institute of Technology
Bachelor of Technology - Mechanical Engineering
K L University