Los Angeles Quality Assurance

Sajal Verma

Los Angeles, CA 323-***-**** ********@***.*** LinkedIn

Detailed oriented Regulatory and quality Assurance professional with 1.5+ years of experience in the US medical device industry. Skilled in supplier quality management, risk mitigation, and regulatory compliance (ISO 13485, 21 CFR 820). Proven track record of reducing CAPA resolution and leading successful FDA audits. Passionate about driving supplier excellence and continuous improvement through teamwork and process optimization. Experience

USC Regulatory Science Consulting Centre - Regulatory Affairs Student Consultant; Los Angeles, CA Jan 2024 - May 2025

● Monitored and trended quality metrics and led monthly review boards.

● Investigated non-conformances and supported SCAR resolution with suppliers.

● Participated in product lifecycle support including change control, design verification, and regulatory submissions.

● Implemented quality training programs to improve internal audit readiness. Exelint International co. - Regulatory Affairs and quality assurance intern; Los Angeles, CA May 2024 - April 2025

● Participated in CAPA teams to investigate and resolve supplier-related issues, including nonconformances and audit findings; supported root cause analysis, impact assessments, and development of effective corrective and preventive actions.

● Assisted in batch record review, product release, and issuance of Certificates of Compliance (CoC) to ensure timely and compliant delivery of clinical supplies.

● Acted as lead facilitator for Process FMEA (PFMEA) workshops across high-volume production lines to identify potential failure modes and implement effective controls.

● Conducted risk assessments as part of engineering changes, nonconformance investigations, and CAPA activities.

● Utilized FMEA tools to proactively reduce process risk and align controls with severity and occurrence ratings.

● Developed and revised SOPs to align with evolving regulatory expectations and internal quality standards; supported document control and cGMP compliance initiatives.

● Conducted risk assessments on manufacturing processes, identified quality gaps, and proposed corrective actions to strengthen process controls.

● Supported QMS improvement initiatives and tracked closure of 100% of audit findings during internal inspections.

● Led regulatory release of clinical supplies, ensuring full compliance with FDA and global regulatory requirements across the end-to-end release process.

Projects

● Amgen Validation Master Plan (USC Project): Developed and presented a comprehensive validation strategy (VMP, IQ/OQ/PQ) for sterile injectable drug product, simulating commercial fill/finish validation process for FDA submission.

● TRAQS: Novel Product Regulatory Licensure Research for US market launch with CertMedica: Acted as a liaison between the firm and the FDA, communicating regulatory requirements to ensure compliance for US market entry. Identified potential regulatory hurdles and developed strategies to mitigate risks, ensuring timely product approvals.

● Supplier Quality Improvement Project: Led supplier CAPA resolutions and implemented PPAP-based qualification strategies to strengthen incoming material quality. Developed control plans and sampling methods while supporting the deployment of Supplier Owned Quality initiatives. Applied Lean Six Sigma methodologies to enhance supplier performance and process efficiency, ensuring audit readiness in compliance with ISO 13485 and FDA 21 CFR 820. Skills

Quality Systems: CAPA, SCAR, NCR, FMEA, Risk Management. Process Validation: IQ/OQ/PQ, Cleaning Validation, GMP Compliance Regulatory Standards: FDA 21 CFR 820, ISO 13485, EU MDR Soft Skills: Cross-functional collaboration, Communication, Time Management, Teamwork Interests: Chess, Graphic Design, Singing, Coding (Learning Python) Education

Master of Science in Medical Product Quality

University of Southern California, Los Angeles, CA, USA Bachelor of Pharmacy

Maharashtra Institute of Technology (MIT WPU), Pune, MH, IN

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