Lubna Khaleefa
Phoenix,USA
Summary
Quality Systems Analyst with experience supporting pharmaceutical and healthcare organizations through Quality Management System (QMS) activities, CAPA management, nonconformance investigations, change control, complaint handling, training compliance, and regulatory documentation. Knowledgeable in FDA regulations, cGMP, GDP, ISO 9001, and 21 CFR requirements. Proven ability to drive quality improvements, perform root cause investigations, maintain compliance, and collaborate cross-functionally to support inspection readiness and operational excellence.
Overview
7
7
years of professional experience
Work History
Quality system analyst
CAPS
Phoenix, Arizona
08.2025 - Current
- Oversaw Quality Improvement Processes by issuing weekly updates on record status and leading bi-monthly Quality Council meetings, including presentation of key quality metrics and performance trends.
- Managed CAPA system and audit observations end-to-end, ensuring timely closure and presenting monthly CAPA Review Board updates to senior leadership and cross-functional stakeholders.
- Maintained QMS records and ensured timely closure of quality system activities.
- Collaborated with the Quality team to prepare and present Quality System Management Review (QSMR) reports by compiling and analyzing quality metrics, CAPA status, complaint trends, audit findings, and continuous improvement initiatives for leadership review.
- Reviewed and approved quality system documentation to ensure compliance with FDA regulations, cGMP requirements, ISO 9001 standards, and internal procedures.
- Conducted quality reviews of laboratory records, analytical data, laboratory notebooks, and supporting source documentation.
- Supported internal & external audits and inspection readiness activities by maintaining compliant documentation and quality records.
- Delivered training on SOPs, GMP, GDP, quality systems, and regulatory requirements to promote company-wide compliance.
- Collaborated with cross-functional teams to investigate deviations, identify corrective actions, and drive continuous improvement initiatives.
Quality Assurance Specialist II
Covetrus
Phoenix, US
07.2022 - 05.2024
- Develop and implement a checklist for verifying certificate of analysis results to ensure consistency and compliance.
- Managed complaint and nonconformance processing through records and tracking systems, conducting root-cause analysis and implementing corrective and preventive actions (CAPA).
- Assist to ensure compliance with quality plans, documentation requirements, ISO standards, and other regulatory agency requirements.
- Familiar with industry quality standard requirements including a working knowledge of 21 CFR 820, CGMPs, ISO 9001 standards, and the Drug Quality & Security Act
- Documented quality assurance activities through internal reporting and audits.
- Identify training needs and provide training on procedures, FDA regulations GMP, GDP, and quality documents to ensure company-wide compliance
- Review of laboratory notebooks and other source data
- Ensure all QMS requirements are met and compliant
- Maintains and updates essential Laboratory documents as per current Regulatory Guidelines
Non-sterile compounding Pharmacy Technician
Covetrus
Phoenix, US
06.2021 - 07.2022
- Daily compounding of suspension and solutions and documented it in the compounding log.
- Measuring quantities, mixing ingredients, packaging medication, and updating records
- Calibrating beakers & quality control.
- Updating SOPs.
- Weekly and monthly lab cleaning
Pharmacy Technician Trainee
ONEPOINT PATIENT CARE
Phoenix, US
10.2020 - 02.2021
- Prepare, pack and label medications in a fast paced environment.
- Track inventory, file paperwork and maintain records.
Medication management call center
University of Arizona
Tucson, US
10.2019 - 05.2020
- Reviewed patient medication lists for accuracy, ensuring all files were up to date.
- Collaborated with pharmacist to confirm patients received appropriate medications and comprehensive care.
Education
Bachelor's - PHARMACEUTICAL SCIENCES
UNIVERSITY OF ARIZONA
Tucson, AZSkills
- CAPA management
- Corrective and Preventive actions CAPA
- Root cause analysis
- Change controls
- Quality management systems
- Quality audits
- ISO 9001 standards
- 21 CFR 820
- SOP management
- Regulatory compliance
- Documentation management
- Process validation
- Quality process improvement
- Quality improvements
- Issue identification
- Data analysis techniques
- Problem solving
- Attention to detail
- Training development
Timeline
Quality system analyst
CAPS
08.2025 - Current
Quality Assurance Specialist II
Covetrus
07.2022 - 05.2024
Non-sterile compounding Pharmacy Technician
Covetrus
06.2021 - 07.2022
Pharmacy Technician Trainee
ONEPOINT PATIENT CARE
10.2020 - 02.2021
Medication management call center
University of Arizona
10.2019 - 05.2020
Bachelor's - PHARMACEUTICAL SCIENCES
UNIVERSITY OF ARIZONA