Hasina Rajabali
Regulatory & Quality Professional | Guiding Medical Device, IVD, Combination Product & Biotechnology Companies Through Compliance & Innovation
- Role
- Senior Quality Assurance Specialist at Veracyte, Inc.
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Hasina Rajabali
Experienced Quality Professional with a passion for process development, optimization, and improvement. Broad background in the areas of quality engineering, Microsoft Office, Standard Operating Procedure SOP/development and regulatory affairs within regulated pharmaceutical, medical device, healthcare informatics, industrial & consumer products. Experienced in multiple FDA inspections and audits with emphasis on cGMPs such as 21 CFR Part 820, 13485, EU MDR. In depth knowledge of Lean Six Sigma (Black and Green Belt) tools and the importance of process/systems improvements through data analysis. Excellent communication skills across all levels of an organization.
Experience
Senior Quality Assurance Specialist
Dec 2025 — Present
Education
University of Illinois Urbana-Champaign
Bachelor of Science - BS
Skills
- Iso 14971
- Regulatory Affairs
- Corrective and Preventive Action (Capa)
- U.s. Food and Drug Administration (Fda)
- Trackwise
- Complaint Investigations
- Validation
- Quality Assurance
- Design Control
- Product Complaints
- Pilgrim
- 21 Cfr
- Quality System
- Fda Gmp
- Lims
- Microsoft Office
- Gdp
- Aseptic Technique
- Siebel
- Fmea
- Standard Operating Procedure (Sop)
- Sop
- Change Control
- Fda
- Lead Internal Auditor
- Quality Auditing
- Glp
- 21 Cfr Part 11
- Iso 13485
- U.s. Title 21 Cfr Part 11 Regulation
- Failure Mode and Effects Analysis (Fmea)
- Medical Devices
- Capa
- Quality Control
- Gmp
- Post Market Surveillance
- Good Laboratory Practice (Glp)
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