Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Krupa Patel

Summary

Experienced Quality Assurance professional in cell therapy with a strong record of ensuring regulatory compliance and driving quality improvement initiatives. Seeking new opportunities to contribute expertise in optimizing processes and ensuring product quality within a dynamic organization in the biotechnology or pharmaceutical sector.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Quality Assurance Shop Floor Specialist

Bristol Myers Squibb
08.2022 - Current
  • Enhance and cultivate relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and various departments to facilitate the efficient execution of responsibilities, drive improvements, and swiftly address any issues.
  • Execute Quality Assurance (QA) shop floor activities with a primary focus on Manufacturing Operations. Ensure strict adherence to established procedures and production specifications.
  • Conduct real-time review of manufacturing records to maintain accuracy and compliance.
  • Perform packout and shipping of drug product. Creating shift report. Resolve all exceptions promptly within the Electronic Manufacturing execution systems.
  • Conduct Line Clearance for all manufacturing processes to uphold cleanliness and safety standards. Maintaining ISO7 gown qualification status and observe manufacturing operations in support of cleanroom behaviors and aseptic techniques. Receive and acknowledge receipt of MBRs and associated forms.
  • Perform quarantine and/or destruction of released for use materials, intermediate products, and final drug products
  • Manage the closure of Deviations, conduct thorough GMP walkthroughs of cleanrooms, and perform meticulous logbook review.
  • Review and approve SOPs, CAPAs, Deviations, Change controls and Quality Risk Management.
  • Support all regulatory inspections and site readiness audits.
  • Provide OJT/ILT training to new quality members.

Clinical Manufacturing Associate (CAR-T)/ Trainer

Minaris Regenerative Medicine
10.2018 - 12.2020
  • Processed, cultured, cryopreserved, and manipulated cell products using aseptic techniques, adhering to written Standard Operating Procedures (SOPs) in accordance with facility Good Laboratory Practice (GLP), Good Tissue Practice (GTP), and Good Manufacturing Practice (GMP) standards.
  • Executed product manipulations according to established SOPs and batch records, encompassing enrichment, depletions, cell expansions, or volume reductions to achieve predetermined endpoints. Additionally, proficiently prepared cell culture media. Conducted cryopreservation of products employing DMSO-based solutions and controlled-rate freezers.
  • Operated and maintained equipment with proficiency, adhering to designated procedures. Equipment included COBE 2991 cell washer, Sepax, Clinimacs, Lovo, DynaMag, Plasmatherm, Xuri wave bioreactor, Maxcyte, Ficoll, controlled-rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipettes, refrigerators, ultra-cold freezers, water baths, tube sealers, dry shippers, centrifuges, and sterile connection devices.
  • Thawed and/or washed cryopreserved hematopoietic progenitor cell products as specified by SOPs.

Quality Assurance Summer Intern

Minaris Regenerative Medicine
06.2018 - 08.2018
  • Assisted in coordinating and managing laboratory space and inventory for a project.
  • Contributed to the customer intelligence and relationship management system by conducting research, performing data entry, and validating information. Liaised with vendors to obtain TSE/BSE Certificate of Analysis.
  • Handled various administrative tasks including filing and data entry, such as scanning and organizing Deviations, NOE, EAL, and CAPA documents.

Education

Bachelor of Arts - Biology

Rutgers University Newark
Newark, NJ

Skills

  • Regulatory Compliance Knowledge (FDA)
  • Batch Record Review and Documentation
  • CGMP, Change Control and Management
  • Troubleshooting and Problem-Solving Strong analytical skills

Certification

Lean Six Sigma White Belt

Basic Life Support (CPR)

Timeline

Quality Assurance Shop Floor Specialist

Bristol Myers Squibb
08.2022 - Current

Clinical Manufacturing Associate (CAR-T)/ Trainer

Minaris Regenerative Medicine
10.2018 - 12.2020

Quality Assurance Summer Intern

Minaris Regenerative Medicine
06.2018 - 08.2018

Bachelor of Arts - Biology

Rutgers University Newark

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Krupa Patel