Quality Assurance Project Management

GHAZALEH AZARANI

Gaithersburg, MD *****

240-***-**** - **********@*****.***

PROFESSIONAL SUMMARY

Accomplished Sr. Quality Assurance Professional with a proven track record at NIH and more than 10 years of experience in document control, audit coordination, and project management. Excelled in enhancing quality systems and fostering teamwork. Known for dependability and a keen attention to detail, significantly improving project delivery and compliance standards.

WORK HISTORY

11/2021 to 10/2024 Sr. Quality Assurance Specialist- NIH GuideHouse

• Develop, implement and maintain a comprehensive Quality Management System

(QMS) to ensure compliance with customer and regulatory standards.

• Led quarterly training workshops on GMP practices, resulting in a 20% decrease in non-conformances within the QC and formulation teams.

• Lead monthly quality audit activities to ensure compliance with QMS requirements leading to a 10% boost in overall quality system effectiveness.

• Contributed to the establishment of an electronic documentation system which improved traceability and reduced document retrieval time by 70%.

• Develop and maintain key process indicators and other quality metrics to track performance and identify areas of improvement.

• Create and implement corrective and preventive action plans to address areas of non- compliance.

• Lead cross- functional teams of technicians to develop and deploy quality control protocols and procedures leading to a 16% increase in on-time project completion 02/2019 to 11/2021 QA Analyst- National Institute of Health (NIH) Medical Science and Computing

• Manage the Corrective and Preventive Actions (CAPA) process, ensuring CAPAs are initiated, investigated and implemented effectively and that appropriate Effectiveness Checks are in place, as needed.

• Leveraged Jira for defect tracking and project management to maintain timely response, achieving a 15% reduction in deviation closure.

• Collaborated closely with the R&D department to embed quality assurance processes early in the development lifecycle, which reduced product development cycles by 3 months on average.

• Collaborate with stakeholders to address CAPA effectiveness issues and escalate unresolved issues when necessary, resulting in a 30% increase in compliance with FDA regulations.

• Train and support stakeholders relating to the deviation/CAPA process, Investigations including Root Cause Analysis and Risk Assessment

• Identify trends and recurring issues from deviation and CAPA data, recommending process improvements or preventive actions.

01/2016 to 02/2019 Quality Assurance Specialist

Prometic BioTherapeautics

• Led the CAPA program and Monitored compliance of procedures with industry standards reducing non-compliance issues by 15%.

• Implemented ongoing quality training programs for an increase of 20% in staff proficiency in Laboratory Investigations Reports, Deviations, Corrective and Preventive Actions, and Change Controls to resolve potential Equipment, Validation, and Analytical testing issues.

• Managed Master Control system in the creation and review of documents used in Development, Analytical Testing, Drug Product Release, and Stability practices for accuracy and completeness in the R&D phase.

• Performed audits of internal controls and risk assessments as well as external audits on vendors

• Initiated, reviewed, and approved Summary of Testing and Certificates of Analysis for external CMOs, CROs etc., reducing human error by 45% and increasing report generation speed by 60%.

• Assisted in the review and approval of stability documentation for use in investigational new drug application (IND) submission. 12/2011 to 01/2016 Quality Assurance/Control Associate Fisher Bioservices

• Streamlined the CAPA process, cutting issue response time by 35% and ensuring rigorous compliance with industry quality standards.

• Implemented a company-wide adoption of ISO 13485 standards, leading to a 20% improvement in audit readiness and enhancing our reputation for quality in the market.

• Designed and executed a comprehensive data quality management strategy, improving data accuracy by 95% and facilitating more reliable business intelligence.

• Increased team efficiency by 40% by implementing a cloud-based Quality Management System (QMS), leading to more timely and accurate reporting across all operations.

EDUCATION

08/2017 Master of Science: Biotechnology Management University of Maryland - University College – College Park, MD SKILLS

• Proficient knowledge and application of

FDA and EU regulations (cGMP, GLP,

Data Integrity).

• Experience with reviewing and

approving CAPA records, Effectiveness

check and root cause analysis

• Excellent communication and

interpersonal skills.

• Problem Solving

• Team Leadership

• Proficient in Quality Management

System (QMS) such as LIMS, Jira and

Master Control.

• ISO standards knowledge

• Root- Cause Analysis

• Regulatory Affairs

• Documentation

• Auditing

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