Lubna Khaleefa
Phoenix
Summary
Highly skilled Quality Assurance Specialist with a comprehensive understanding of QA methodologies in diverse industries. Possess strong analytical skills and the ability to identify risks and defects, ensuring compliance with quality standards. Demonstrated success in implementing effective QA strategies that have improved operational efficiency. Skilled at fostering positive relationships with team members and stakeholders to ensure project success.
Overview
5
5
years of professional experience
Work History
Quality Assurance Specialist II
Covetrus
Phoenix
07.2022 - 05.2024
- Develop and implement a checklist for verifying certificate of analysis results to ensure consistency and compliance.
- Generate and review Sops (Standard Operating Procedure) reports and logs.
- Maintain complaint and nonconformance processing through records and tracking systems, including root-cause analysis and corrective and preventive actions (CAPA)
- Assists 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
- Document quality assurance activities with internal reporting and audits
- Identify training needs and provide training on procedures, FDA regulations GMP, GDP, and quality documents to ensure company-wide compliance
- Perform Quality reviews, and organize and file records that support operation activities.
- Review day -to-day analytical data generated in the Laboratory
- 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
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
10.2020 - 02.2021
- Prepare, pack and label medications in a fast pace environment.
- Track inventory, file paper work and maintain records.
Medication management call center
University of Arizona
Tucson
10.2019 - 05.2020
- Review patient's medication list for accuracy while making sure all files are updated.
- Work with pharmacist to ensure patients are receiving the correct medication and care.
Education
Bachelor's - PHARMACEUTICAL SCIENCES
UNIVERSITY OF ARIZONA
Tucson, AZ05.2020
Skills
- Quality control
- Laboratory procedures
- Quality audits
- QA/QC
- Quality assurance
- ISO 9001
- Root cause analysis
- Corrective actions
- Standard operating procedures
- Regulatory compliance
- Documentation management
- Training development
- Quality management systems
- Attention to detail
- Effective communication
- Problem solving
- Time management
- ISO 9001 standards
- Staff training
- 21 CFR 820
- Microsoft Office
- Quality Management systems
- Science and research
- Computer skills
- Internal Audits
- Calibration
- Laboratory experience
- Customer Service
- Compounding medications
Timeline
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