Ghazaleh Azarani
Gaithersburg,MD
Summary
Accomplished QA Analyst with a proven track record at NIH and extensive 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.
Overview
13
13
years of professional experience
Work History
QA Analyst- National Institutes of Health (NIH)
GuideHouse
11.2021 - Current
- Perform writing and review of a variety of research documents including but not limited to SOP's, Batch Production Records, proposals, reviews, letters of recommendation, and other programmatic documents in preparation
- Maintain and record notes at assigned meetings to collect information to develop Gantt charts, timelines, and other deliverables for the program
- Responsible for QA and reviewing documents for accuracy before submission to regulators, upper management, and international collaborators working with program on various projects
- Provide project management support in all areas of the program through clear communication on agenda items to provide high level objectives and specific action items in notes
- Assist with collaborations in various ways in support of programs mission activities
- Provides support for program through functional operations, explaining programmatic processes and procedures, and maintaining a high level of quality assurance for program
- Provide support for both scientific and administrative members to communicate progress of projects and takes notes to create an action item list for participants
- Perform inventories and monitors offsite repository responsible for safely maintaining clinical grade malaria vaccines intended for use in human clinical studies
- Assist with QA of documents that include SOP's, Batch Production Records and other documents, upload documents into MasterControl
- Train new staff in MasterControl, software validation, review and sign off on approved protocols
- Assist with updates and change management for MasterControl, Jira and other regulatory management applications
- Review and annotate Batch Production Records related to the development and analytical planning for technology transfer to contract manufacturing organizations; provides weekly and quarterly reports of project progress from the contract manufacturing organizations
- Perform regulatory application in relation to MasterControl at NIH to allow the lab to maintain compliancy with established policies
- Provide support to the lab through development of functional operations, definition of standards and execution of programs goals and missions.
Project Coordinator - National Institutes of Health (NIH)
Medical Science and Computing
02.2019 - 11.2021
- Manages the quality assurance responsibilities (QA) for three government clients at the NIH
- Works closely with pre-clinical teams to ensure that all QA documents are accurate and submitted on time
- Leads bi-weekly meetings focusing on coordinating deliverable timelines across pre-clinical working groups
- Monitors the progress of tasks for NIH departments and external contractors/ and initiates early remedial action when agreed timelines are not likely to be achieved
- Generates and revises standard operating procedures (SOPs) and associated documents
- Reviews and approves Change Control, Deviation, and Corrective and Preventive Actions (CAPA)
- Identifies compliance risks and escalates issues to appropriate levels of management for resolution
- Captures metric information for use in continuous improvement of areas of responsibility and reports to management.
Quality Assurance Specialist
Prometic BioTherapeautics
01.2016 - 02.2019
- Reviewed and approved of deviations, investigations, Out-off-Specification (OOS) and change control requests in accordance with industry standards and requirements
- Led the Corrective Actions and Preventive Actions (CAPA) program
- Trained lab technicians to accurately complete Laboratory Investigations Reports, Deviations, Corrective and Preventive Actions, and Change Controls to resolve potential Equipment, Validation, and Analytical testing issues
- Oversaw the creation and review of documents used in Development, Analytical Testing, Drug Product Release, and Stability practices for accuracy and completeness
- 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
- Assisted in the review and approval of stability documentation for use in investigational new drug application (IND) submission.
Quality Assurance/Control Associate
Fisher Bioservices
12.2011 - 01.2016
- Performed technical reviews of manufacturing batch records to ensure compliance with cGMP, regulatory requirements, and internal procedures
- Performed investigations, CAPAs, Deviations and QA holds based on review
- Reviewed and approved investigations associated with atypical results, discrepancy reports, and out of tolerance documentation
- Reviewed stability data to ensure accuracy and conformance to product specification
- Created, revised, and trained staff on standard operating procedures
- Approved batch records for product release.
Inventory Technician
Fisher Bioservices
12.2011 - 12.2012
- Handled specimens of human, animal, and plant origin.
Education
Master of Science - Biotechnology Management
University of Maryland - University College
Hyattsville, MDSkills
- Dependable and Responsible
- Teamwork and Collaboration
- Data Management
- Audit Coordination
- Risk Analysis and Mitigation
- Attention to Detail
- Quality Systems
- Project Management
- Quality control tests
- Quality Standards Determination
- Knowledge of quality systems
- Document Control
- Audit reporting
Timeline
QA Analyst- National Institutes of Health (NIH)
GuideHouse
11.2021 - Current
Project Coordinator - National Institutes of Health (NIH)
Medical Science and Computing
02.2019 - 11.2021
Quality Assurance Specialist
Prometic BioTherapeautics
01.2016 - 02.2019
Quality Assurance/Control Associate
Fisher Bioservices
12.2011 - 01.2016
Inventory Technician
Fisher Bioservices
12.2011 - 12.2012
Master of Science - Biotechnology Management
University of Maryland - University College
Similar Profiles
Dustin AntolickDustin Antolick
Ivestigoator-Analyst at GuidehouseIvestigoator-Analyst at Guidehouse
Kevin Welch Jr.Kevin Welch Jr.
Partner Account Director – (Public Trust) at GuidehousePartner Account Director – (Public Trust) at Guidehouse
Adrienne DollmeyerAdrienne Dollmeyer
Patient Account Representative at GuidehousePatient Account Representative at Guidehouse
Akhil AlexAkhil Alex
Senior AR Caller and Analyst at GuideHouseSenior AR Caller and Analyst at GuideHouse
Bilal SadiqBilal Sadiq
Property Owner at Self-employedProperty Owner at Self-employed