Quality control and analytical scientist
Resume:
EDUCATION
FATHIMA
MUHAMMAD
ANALYTICAL SCIENTIST
CONTACT
************@*****.***
SKILLS
Analytical Problem-Solving
Regulatory Document Preparation
and Submission
Compliance and Quality
Management
GMP/GLP Documentation
Technical Writing for Regulatory
Submissions
Regulatory Knowledge (FDA, ISO,
cGMP, industry best practices)
Meticulous Attention to Detail
Proficiency in Regulatory Software
(e.g., Veeva, ComplianceWire,
ZenQMS)
Expertise in Microsoft Office Suite
(report preparation, tracking
systems)
REFERENCE
Email :
Irene Garnett
Phone:
Rocket Pharmaceuticals/ Principal
Scientist
Roksana Rahman
Phone:
Email :
QC Manager/ BMS
PROFESSIONAL EXPERIENCE
ANALYTICAL CAR-T SCIENTIST, QC ABECMA
Bristol Myers Squibb/ August 2022-Feb 2023
QC/CLINICAL DIAGNOSTICS ASSOCIATE SCIENTIST, NGS
Azenta Life Sciences (Genewiz) / November 2021– May 2022 Resolved technical challenges in analytical methods to ensure readiness for regulatory review and submission.
Authored, reviewed, validated, and verified analytical methods to confirm their accuracy, reliability, and compliance with industry standards. Acted as a liaison between Analytical Development and Quality Control teams, providing critical input to address FDA inquiries for the recent commercialization submission.
Applied knowledge of regulatory requirements to analytical method development and submission processes.
Led efforts to validate the analytical development lab, ensuring compliance with regulatory standards for equipment and processes." Analyzed and reviewed flow cytometry data, documenting findings for cross-functional collaboration and compliance requirements.
Collaborated with quality assurance and regulatory teams to address compliance issues related to flow cytometry testing.
Increased analyst data review output by 30% by reorganizing QC team responsibilities and training.
Participated in validation and verification of flow cytometry assays, ensuring alignment with regulatory guidelines and quality benchmarks. Applied knowledge of regulatory requirements, such as cGMP and cGLP, in daily QC activities to ensure continuous compliance with industry standards. Worked closely with cross-functional teams, including NGS, library preparation, and sequencing departments, to compile accurate and comprehensive reports. Utilized advanced molecular biology techniques and instrumentation to support quality control and clinical diagnostics.
Prepared detailed reports on experimental findings and quality control metrics for internal and cross-departmental collaboration.
Analyzed data to ensure accuracy, consistency, and compliance with quality standards. Rocket Pharmaceuticals/ July 2023-Present
ASSOCIATE SCIENTIST, ANALYTICAL DEVELOPMENT/ QUALITY CONTROL TISSUE MANUFACTURING LAB TECHNICIAN, ALLODERM
AbbVie (Allergan)/ May 2020 – Sept 2020
Operated in cleanroom environments, adhering to current cGMP and cGLP to ensure the safety and quality highest standards in tissue processing. Maintained meticulous documentation of manufacturing processes, ensuring compliance with internal protocols and external regulatory requirements. Processed human tissue for surgical use in strict compliance with ethical standards, regulatory guidelines, and quality assurance protocols. Monitored cleanroom operations and proactively addressed compliance risks to maintain a sterile and compliant manufacturing environment. Collaborated with cross-functional teams to troubleshoot process issues and enhance operational efficiency.
WILLIAM PATERSON UNIVERSITY
B.S. Biotechnology
MIDDLESEX COUNTY COLLEGE
A.S. Biotechnology
RESEARCH ASSISTANT, MIOCROBIOLOGY/ GENETICS
William Paterson University / December 2019– August 2021 Prepared detailed reports and maintained precise documentation of experimental results, ensuring compliance with laboratory standards. Authored concise summaries of research findings and prepared presentations for scientific audiences.
Troubleshot experimental issues, optimizing protocols to achieve reliable and reproducible results.
Conducted rigorous analysis of microbiological and genetic data to identify trends and ensure data quality and integrity.
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