Chanais Lew
Quality Assurance Specialist in Biotech & Cell/Gene Therapy 🧬 | Patient Safety Advocate | First-Gen Latina in STEM
- Role
- Sr Quality Assurance Specialist - Client Qa at Catalent
- Location
- Baltimore, MD, US
- LinkedIn followers
- 500 followers
About Chanais Lew
At 11 years old, I was translating prescriptions and lab results for my mom. As a…
Experience
Sr Quality Assurance Specialist - Client Qa
May 2023 — Present · Baltimore, MD, US
Providing dedicated QA support to client projects and quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product used in Phase I/II clinical trials.• Continually evaluating systems and procedures for improvement to ensure compliance to appropriate regulatory requirements and industry standards and maximizing efficiency.• Supporting GMP departments in performing and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs).• Supporting regulatory (i.e, FDA, EMA) and client audits/inspections.• Working cross-functionally with Project Management, Pre-Clinical Services, Manufacturing, Facilities, Quality Control and other departments to resolve quality issues and aiding when needed.• Maintaining databases and systems used for tracking various GMP manufacturing associated support activities
Education
Bowie State University
Bachelor of Science - BS
2014 — 2018
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