Quality Control Assurance

Jagadesh Gadela

********@*****.*** 203-***-**** New Jersey

Professional Experience:

Detail-oriented QC Analyst with hands-on experience in batch record review, deviation handling, CAPA investigations, product release, and compliance with cGMP, FDA, and ISO standards. Skilled in using Veeva Vault, SAP, Agile, Lims QualiPSO, and Oracle QMS to support quality operations across manufacturing and packaging. Proven ability to identify root causes, drive preventive actions, and maintain audit readiness in a fast-paced, regulated environment. Proficient in ANSI/ASQ Z1.4 sampling plans, AQL inspections, and the application of normal, reduced, and tightened inspection levels. Quality Control Analyst

Novartis Pharma, New Jersey Mar 2025- Present

• Performed product sampling (e.g., sterility, bioburden, endotoxin) per batch production requirements and documented results in accordance with Good Documentation Practices (GDP).

• Performed daily Viable (air, surface, personnel) and non-viable (airborne particle count) Environmental Monitoring (EM) within ISO-classified cleanroom manufacturing areas to ensure compliance with cGMP and aseptic practices. Using pipettes, dilution tubes, instruments NC200, plate reader, and cell dose process and sample handling using bio cabinets, centrifuges.

• Conducted routine EM activities using active air samplers, settle plates, contact plates, and particle counters; ensured all data was logged and reviewed per SOPs and regulatory requirements.

• Prepared media plates (TSA, SDA, RODAC, etc.) daily under aseptic conditions for use in Environmental Monitoring procedures.

• Assisted with manufacturing operations during non-production windows, supporting routine cleaning, line clearance, and preparation for aseptic processing.

• Experience in manual visual AQL inspection for Sterile kits, syringes/vials; conducted visual inspections using ANSI/ASQ sampling plans and made accurate pass/fail decisions based on defect classifications and AQL criteria.

• Investigated and documented deviations in Veeva Vault, performed Root Cause Analysis (RCA), and initiated CAPAs to drive timely and compliant resolutions.

• Utilized SAP and QualiPSO to quarantine/block affected materials, track product disposition status, and ensure traceability of raw materials and finished goods.

• Perform shopfloor activities- manufacturing production labelling floor make sure line clearance, ensure with pre checklist.

• performed routine cleaning and sanitization of controlled environments and production equipment using validated disinfectants, ensuring adherence to facility hygiene standards.

• Monitored inventory and replenished supplies for EM sampling kits, growth media, disinfectants, and gowning materials to ensure uninterrupted operations.

• Authored and managed Non-Conformance Material Reports (NCMRs) for component failures and process discrepancies, using QualiPSO for cross-functional routing and approval.

• Collaborated with Manufacturing and Packaging Operations to provide on-the-floor QA support, address non-conformances in real time, and review logbooks and AQL Inspection Forms for completeness and accuracy.

Integra life sciences, Cincinnati, OH Jul 2024- Mar 2025 Quality assurance specialist -full time

• Conducted receiving, in-process, and final inspections; processed data in Oracle Quality Management Systems (QMS). And created certificate of conformance (CofC).

• Resolve discrepancies in Certificates of Analysis (CoAs), shipping documentation, and incoming inspection paperwork.

• Participated in process improvement initiatives to reduce redundant inspections, optimize sampling plans, and streamline incoming material verification workflows.

• Performed Quality assurance activities on the shop floor, ensuring production, quality control meet cGMP and data integrity requirements

• Reviewed and approved Batch records, Device History Records (DHR), SOPs, work order forms for products, supplier engineer forms, verified vendor documents, manufacturing design protocol, validation protocols, testing records to maintain adherence to regulatory standards.

• Evaluated component drawings and specifications; used precision measurement tools such as calipers and micrometers to verify critical dimensions and attributes of incoming parts.

• Reviewed, approved, and supported production/testing records and procedures while aiding in the training of site associates.

• Performed QA shop floor oversight to monitor in-process inspections, enforce line clearance, and ensure compliance with aseptic and gowning practices in ISO-classified cleanrooms.

• Assisted functional areas in achieving timely and compliant product disposition.

• Perform shopfloor activities and Inspected First Piece Inspections (FP), First Article Inspection (FAI), ensuring production accuracy and design approvals. And ensure production line clearance.

• Maintained compliance with FDA, cGMP, and internal SOPs through consistent documentation practices, adherence to inspection protocols, and routine internal audits.

• Supported investigations related to deviations, out-of-specification (OOS), out-of-trend (OOT), and out- of-expectation (OOE) results, performing testing as required.

• Provided shop floor quality oversight for production, quality control, and supply chain operations to ensure full adherence to cGMP and data integrity standards.

• Inspected products for conformity, escalating CAPA and drafting Non-Conformance Material Reports

(NCMRs).

• Monitored cleanroom environments, conducted internal audits, and enforced adherence to aseptic techniques.

• Collaborated with R&D, manufacturing, and regulatory teams to resolve quality issues and support product launches.

• Utilized statistical tools and techniques to analyze quality data and identify trends for continuous improvement.

• Maintained compliance with cGMP, cGDP, FDA, EU MDR, and ISO standards.

• Utilized SAP, Agile, and Oracle databases for inventory, inspection management, and material rejection tracking.

• Managed quality documentation, including updates to the Device Master Record (DMR) and inspection reports.

• Calibrated and validated equipment, including CUSA hand pieces and test tips; reviewed QA testing data. Unosis Systems, Bengaluru, India Jan 2018 - Jul 2021 Quality Assurance Specialist

• Reviewed and approved Batch Records, Device History Records (DHRs), validation protocols, work orders, and supplier documents in compliance with FDA and ISO 13485 standards.

• Performed QA shop floor oversight to monitor in-process inspections, enforce line clearance, and ensure compliance with aseptic and gowning practices in ISO-classified cleanrooms.

• Handled deviations (minor, major, critical) in Veeva Vault and QualiPSO: conducted root cause analysis, classified impact, initiated CAPAs, and verified effectiveness.

• Quarantined impacted lots and blocked materials in SAP during investigations, and dispositioned them post-approval.

• Authored and managed Non-Conformance Material Reports (NCMRs) for defective components and process issues, collaborating with suppliers and engineering teams.

• Led Corrective and Preventive Actions (CAPAs) for repeated quality issues, including SOP revisions, staff retraining, and procedural audits.

• Conducted AQL inspections for final release and documented all findings in Oracle QMS.

• Ensured compliance with cGMP, cGDP, FDA, EU MDR, and internal audit procedures.

• Supported audit readiness by maintaining up-to-date SOPs, DMRs, and inspection logs, ensuring traceability and data integrity.

Technical Skills:

• Quality Management Systems (QMS): Supplier Quality, Design Controls, DMR, DHR, FMEA, TMV

• Regulatory Compliance: ISO 9001,13485, FDA 21 CFR Part 820, EU MDR, cGMP, cGDP, cGCP.

• Quality Tools: CAPA, GAP Analysis, GD&T

• Technical Proficiency: SAP, Oracle, Agile, Microsoft Excel, Word, ERP, Outlook, Smartsheet, Google sheet, Statistical Analysis, Precision Tools, Veeva-vault, Track Wise, Data Integrity, LIMS, Condour, QualiPSO.

• Visualization tools- Tableau desktop, Power BI

• Batch Record Review Discrepancy Escalation, CAPA, Shop Floor oversight.

• Change Control Templates/Portals – To support QA in review and approval processes.

• Electronic Document Management Systems (EDMS) – For SOP access, logbook reviews, and controlled documents

• Deviation Management Systems – For documenting and tracking non-conformances and rework operations.

Education:

Masters in Healthcare Informatics Sacred Heart University, CT Bachelors in Doctor of Pharmacy MGR University, India

Contact this candidate