Sai Kummithi
Regulatory Affairs Professional | MS - Regulatory Affairs | Northeastern University
- Role
- Quality Control Specialist at BD
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Sai Kummithi
Aspiring to make a difference in the pharmaceutical sector as a regulatory affairs professional; ambitious student with a passion for policymaking. Fluent in ICH and FDA protocols, with extensive experience in medication development and submission. Competent in both tactical and strategic problem-solving; capable of generating original ideas for addressing complex regulatory issues. Excellent verbal and written communication abilities. I am an advocate for innovative patient care and am looking for a position where I can put my skills to use in regulatory affairs.
Experience
Quality Control Specialist
Apr 2025 — Present · Lexington, MA, US
Conducted Quality Control checks by using calibrated measuring tools and following testing protocols to verify product specifications.• Maintained Quality Systems (QMS) by documenting quality records, updating procedures, and following established guidelines to support compliance.• Performed data analysis and documentation reviews to ensure conformance to specifications, including calculations using Excel spreadsheets.• Verified Device History Records (DHR) by reviewing documentation for accuracy and ensuring compliance with regulatory requirements before final approval.• Maintained lot history records, ensuring proper documentation before product disposition and final shipping authorization.• Assisted in writing and reviewing inspection and test procedures for incoming, in-process, and finished product quality assessments.• Coordinated calibrations and updated the calibration log, ensuring compliance with regulatory requirements.• Participated in environmental monitoring reviews to uphold quality and safety standards.• Supported Quality Systems, including internal audits, and Management Review preparations.• Assisted with Environmental Monitoring by collecting air and surface samples, recording data, and reporting contamination risks in controlled areas.
Education
Annamacharya College of Pharmacy, Rajampet
Bachelor of Pharmacy - BPharm, Pharmacy
Northeastern University
Ms in Regulatory Affairs, Pharmacy
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