Naafiah Noor
RAC-Drug Holder| CMC/ External Mfg. Co-op at Beam Therapeutics| Graduate at Northeastern University (MS in Regulatory Affairs)| Business process lead at TCS | Operations Specialist at IQVIA | Bachelor in Dental Surgery.
- Role
- Cmc External Manufacturing Co-op at Beam Therapeutics
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Naafiah Noor
As a dedicated Graduate Student in Regulatory Affairs with a professional background in…
Experience
Cmc External Manufacturing Co-op
Jul 2025 — Present · Cambridge, MA, US
Regulatory Filing: Assisted in GMP document compilation for Module 3 of BLA/Marketing Authorization filing process, using Smartsheet, reducing time and increasing efficiency by nearly 50%. Risk Management: Supported quality assurance activities, including 3 deviation report closure and CAPA generation, change control, OOS and impact assessment to maintain. Gap Assessment: Utilized the knowledge of products and business to ensure appropriate cross-functional training materials (20+SOP links, 2 process flowcharts, 1 abbreviation guides) to strengthen continuous learning. Manufacturing Documents: Supported in batch records and technical documentation, Certificate Analysis, QTA, collaborating with quality, supply chain and regulatory.
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