Nabila Ali
Allentown,PA
Summary
Dedicated professional specializing in batch release and deviation management. Proven leadership and mentorship abilities enhance quality assurance processes and ensure compliance in dynamic environments.
Overview
22
22
years of professional experience
Work History
Quality Coordinator/Quality Assurance
CAPS (B. Braun)
Allentown, PA
09.2019 - Current
- Review and release Compounded Sterile Preparation (CSP) batch records.
- Investigate quality events, deviations, and nonconformances using TrackWise.
- Ensure compliance with cGMP, SOPs, and regulatory requirements.
- Trained and mentored employees on batch record review procedures to ensure compliance.
- Received recognition for enhancing batch record review processes.
- Subject Matter Expert (SME) for Batch Record Review, NS-S Compounding, and Vaisala Monitoring System.
- Manage controlled documents within EDMS.
- Manage equipment calibration activities through Blue Mountain (BMRAM).
- Led improvements to documentation accuracy and operational efficiency.
Quality Control Associate (ISS)
Sharp
Allentown, PA
01.2019 - 09.2019
- Conducted cGMP-compliant quality control inspections and reviewed documentation to maintain compliance standards.
- Provided quality oversight and monitored compliance to support effective manufacturing operations.
- Monitored adherence to safety, quality, and regulatory requirements to ensure operational integrity.
Research Associate
Kuwait University
Hawalli, Kuwait
01.2005 - 12.2017
- Executed ELISA, EIA, IFA, DFA, IHA, antibody, and cytokine assays to support research objectives.
- Developed and optimized research protocols and testing methods.
- Analyzed data and addressed analytical and instrumentation issues to enhance research reliability.
- Conducted laboratory research and quality assurance testing using biochemical and immunological techniques.
Education
Bachelor of Science - Biochemistry
University of Karachi
PakistanBachelor of Science - Biochemistry
University of karachi
PakistanSkills
- cGMP compliance
- Batch release
- Deviation management
- Change control management
- Quality CAPA
- Documentation management
- Internal auditing
- Environmental monitoring
- Raw material inspection and release
- Material inspection with SAP
- BMRA calibration
- Calibration and equipment management
- Vaisala expertise
- Electronic document management systems (EDMS)
- MasterControl review
- Staff training and mentoring
Timeline
Quality Coordinator/Quality Assurance
CAPS (B. Braun)
09.2019 - Current
Quality Control Associate (ISS)
Sharp
01.2019 - 09.2019
Research Associate
Kuwait University
01.2005 - 12.2017
Bachelor of Science - Biochemistry
University of Karachi
Bachelor of Science - Biochemistry
University of karachi