Abhishek Kashalikar
Quality Control Compliance Investigator @ Minaris Advanced Therapies
About
GMP Quality Professional with 3+ years of experience in QC microbiology and deviation investigations supporting CAR-T manufacturing. Background includes sterility, endotoxin, mycoplasma, and EM testing, with exposure to rapid PCR technologies. Currently pursuing an M.S. in Biotechnology at Johns Hopkins University. Actively seeking QA, Sterility Assurance, or analytical roles with a focus on compliance, investigations, and process improvement.
United States
New York City Metropolitan Area
Pharmaceuticals
Deviations, Investigation, Corrective and Preventive Action (CAPA), Veeva, Endotoxin Testing (LAL / Kinetic Chromogenic), Mycoplasma Detection (e.g., BioFire, PCR-based), Environmental Monitoring (ISO 5–8), EM Plate Reading, Aseptic Technique, USP <71>, <85>, <1116> Knowledge, FDA / EU Annex 1 Regulations, Laboratory Information Management System (LIMS), Sterility Testing (USP <71>), GMP / GLP / GDocP Compliance, Cross-Functional Collaboration (QA, manufacturing, labs), Strong Work Ethic, Adaptability in Fast-Paced Environments, Bac-T sterility assay, Endotoxin, Mycoplasma
Experience
Quality Control Compliance Investigator
Minaris Advanced Therapies
Allendale, NJ
- Led investigations for deviations, nonconformances, OOS/OOT, and environmental monitoring excursions. - Performed root causes analysis using structure tools (e.g., 5 Whys, fishbone diagrams). - Developed and implemented corrective and preventive actions (CAPA) to prevent recurrence. - Managed multiple investigations simultaneously, ensuring compliance with timeliness and product release needs. - Collaborated with cross-functional teams (QC, QA, Operations) to assess impact and define actions. - Established and reviewed trending rules to trigger corrective actions. - Analyzed process and EM data to identify trends and improvement opportunities. - Supported change management activities to ensure corrective actions were effectively
QC Analyst II/Microbiology Specialist II
Legend Biotech
Raritan, NJ
Worked alongside with Janssen pharmaceuticals (Johnson & Johnson)
Clinical Microbiology/ Molecular Technician
Aculabs Inc.
East Brunswick, New Jersey, United States
Undergraduate Research Assistant
Rutgers School of Environmental and Biological Sciences
New Brunswick, NJ
- worked on mini projects related to Molecular Biology - worked at Dr.Bruce B Clarke research laboratory in Turfgrass pathology -worked at Bradley I. Hillman research laboratory
Education
Johns Hopkins University Advanced Academic Programs
Biotechnology
Concentration in Molecular Targets and Drug Discovery
Rutgers University
Biotechnology
Abhishek Kashalikar's Contact Information
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