Tejal Amin

Seeking challenging position in pharmaceutical, biotechnology and medical device industry

QC Senior Associate Scientist (CAR-T Cell Therapy, Bio-analytical) - Bristol Myers Squibb - Warren, NJ

(2021-04)

• Bioanalytical QC testing and reporting for clinical cell therapy products
• Performs in-process, final product, and stability sample testing to support clinical release of cell therapy products.
• Utilizes analytical methods including ELISA, Flow Cytometry, qPCR, and aseptic technique.
• Operates under GMP and GDP regulations to ensure compliance and product quality.
• Authors and reviews technical documents such as SOPs, test methods, and stability protocols/reports using Veeva.
• Conducts deviation (QE), CAPA, and OOS investigations to support continuous improvement and regulatory compliance.
• Serves as Subject Matter Expert (SME) responsible for training new employees.
• Participates in QC group meetings and cross-functional projects to drive collaboration and process optimization

QC Serologist II – Reagent Red blood Cell - Ortho Clinical Diagnostics (Johnson & Johnson) - Raritan, NJ

(2010-07 - 2021-04)

• Performed serological testing of biological raw materials and blood bank reagents.
• Conducted in-process, release, stability, and customer complaint testing.
• Conducted testing on Ortho AutoVue Innova and ProVue systems.
• Maintained and troubleshot laboratory equipment to ensure optimal performance.
• Reviewed documentation in accordance with approved procedures and GMP standards.
• Served as Subject Matter Expert (SME) responsible for training new employees.
• Conducted batch record review and participated in non-conformance (NC) and CAPA investigations.
• Managed scheduling and coverage for two laboratories to ensure continuous operations.

Post Diploma - Medical Laboratory Technology - Maha Gujarat Hospital (1999)

Bachelor of Science - Microbiology - Gujarat University (1998)