Harshil Patel
Analytical Quality Scientist at BioLink Life Sciences Carolinas Inc.
- Role
- Associate Scientist at Biolink Life Sciences
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Harshil Patel
Quality Specialist with 6+ years of experience in cGMP pharmaceutical environments…
Experience
Associate Scientist
May 2025 — Present · Cary, NC, US
Lead and coordinate end-to-end Quality Control project lifecycles• Plan and track method development, validation, and stability study timelines.• Coordinate process improvement initiatives using Lean Six Sigma to reduce errors and improve workflow efficiency.• Investigate deviations, OOS/OOT results, and implement CAPA actions to maintain compliance.• Streamline documentation and reporting systems to enhance traceability and audit readiness.• Collaborate with cross-functional teams to align testing schedules and project goals.• Ensure laboratory operations, documentation, and audits comply with SOPs, quality systems, and safety policies.• Perform analytical testing of client samples using HPLC, Dissolution, and UV-Vis under cGMP standards.• Support junior staff with training on documentation, data review, and analytical procedures.• Monitor equipment maintenance and resource utilization to ensure operational efficiency.
Education
Harrisburg University of Science and Technology
Master of Science - MS
Gujarat University
Bachelor of Science - BS
Oregon State University
Professional Science Master - PSM
Indrashil University
Master of Science - MS
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