Sri Rama Lakshmi Devi Nekkanti
Quality Assurance Specialist @QIAGEN
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WORK HISTORY
Quality Assurance Specialist @QIAGEN
Beverly, MA, US
Managed NCMRs, Deviations, Change Requests, and CAPAs, leading investigations, performing root cause analysis (5 Whys, Fishbone Diagram, FMEA), and implementing effective corrective and preventive actions.• Led supplier quality management by conducting supplier evaluations, approvals, and periodic re-evaluations based on performance metrics, audit results, and risk assessments and ensured full compliance with ISO 13485 and cGMP standards.• Supported internal, certification, and customer audits by preparing documentation, guiding audit teams, and maintaining continuous audit readiness.• Tracked and reported global KPIs and quality metrics to improve compliance visibility and drive quality improvements.• Authored, reviewed, and maintained SOPs and Work Instructions in TrackWise and MasterControl for effective document control and QMS compliance.• Conducted lab walkthroughs to ensure compliance with Good Laboratory Practices (GLP) and identify process improvement opportunities.• Investigated customer complaints, collaborating with cross-functional teams to identify root causes, resolve issues, and enhance product quality.• Applied strong knowledge of cGMP, GLP, ISO 13485, and 21 CFR Part 820 to ensure regulatory compliance and mitigate product quality risks.• Collaborated closely with cross-functional teams including Quality Control, Research & Development (R&D), and Regulatory Affairs, ensuring seamless implementation and validation of quality systems and processes across departments.
EDUCATION
JSS Academy of Higher Education & Research
Bachelor of Pharmacy - BPharm, Pharmacy
Northeastern University
Master of Science - MS, Regulatory Affairs for Drugs, Biologics and Medical Devices
ABOUT SRI RAMA LAKSHMI DEVI NEKKANTI
Quality Assurance Specialist with 4 years of experience ensuring compliance, process excellence, and continuous improvement in FDA and ISO 13485 regulated medical device and pharmaceutical environments. Skilled in managing key quality system processes, driving root cause analysis, and supporting cross-functional collaboration to enhance manufacturing performance and product reliability.
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