Randa Laouar
Wood,VA
Summary
Detail oriented and analytical Quality Assurance Specialist with 7 years of experience authoring high-quality scientific, medical, and pharmaceutical documentation to explain complex processes clearly and concisely. Extensive academic and hands on experience in bio-analytical chemistry and bio-pharmaceutical manufacturing with a proven ability to work independently with minimal oversight. Proactive with the capacity to work in a fast paced, high workload environment and manage multiple projects and objectives for on-time event closure. Self-starter with exceptional technical writing, editing and proofreading skills.
Overview
9
9
years of professional experience
Work History
Quality Systems Specialist I
Emergent BioSolutions
06.2023 - Current
- Reviewed deviation investigations
- Supported the development and execution of CAPA plans to address identified deviation root causes or compliance/quality gaps
- Coordinated and supported the development and execution of change control plans to ensure compliant implementation of product and/or process changes
- Critically reviewed various types of documentation to ensure completeness, accuracy, and compliance, including Batch Production Records, SOP revisions, protocols, data sets, material specifications, work orders, calibration records, and validation reports
- Served as liaison between manufacturing and engineering departments, facilitating communication on product specifications and requirements.
- Supported site inspections from regulatory agencies including escorting inspectors, speaking as Quality Assurance subject matter expert, and preparing documentation for auditor review
- Facilitated the identification, gathering, analysis and reporting of Quality System performance metrics via the Quality Management Review process, including in-depth analysis of metrics and presentation to the site leadership team
- Partnered with Supply Chain and Global Supplier Quality teams to execute required activities for the qualification and monitoring of suppliers.
- Coordinated the execution of Quality Technical Agreements, Service Agreements, and other related contracts
- Oversaw the coordination of change notifications and performance improvement plans for shared suppliers in a way that allows shared visibility at the site level.
- Maintained and communicated actionable performance metrics for key suppliers using feedback from Emergent’s manufacturing sites
- Provided support for regulatory inspections or customer audits as requested by the sites, before, during and/or after the event.
- Served as reviewer and approver of quality documents such as Corrective Actions, Validation and technical study protocols and other cGMP compliance documentation, ensuring data integrity and traceability, clarity of technical writing, compliance, with SOPs/regulations and suitability for review by regulatory authorities.
- Championed lean initiatives within the organization, promoting waste reduction and overall process efficiency improvements.
Analyst II/III
Emergent BioSolutions
06.2021 - Current
- Authored and resolved Deviations, Change Controls, CAPAs and additional documents to support production needs and meet product release requirements
- Investigated deviations from all departments, performed thorough product impact analysis, utilized root cause analysis tools and worked cross functionally to implement effective CAPAs to reduce deviation recurrence
- Conducted investigational analysis in support of events associated with Fill Finish facility and aseptic processes, including Environmental Monitoring, Component Preparation, Vial Filling, Lyophilization, Capping, RABS, HVAC systems, airlocks, and work environments with various classifications
- Authored CAPAs & CCs to meet production release requirements, support continuous improvement efforts and operational optimization
- Collaborated with area SMEs to write, review, revise and/or prepare manufacturing documents (BPRs, RPTs, SOPs, etc.) in accordance with cGMPs and regulatory guidelines
- Initiated tracking and follow up of complex issues stemming from deviation investigations
- Independently analyzed complex issues using risk appropriate decision making
- Identified and supported interdepartmental continuous process improvement projects (PDSA)
- Monitored deviation performance metrics and presented metrics in Quality Management Review meetings
- Provided audit support as an investigation SME
- Developed and conducted investigation awareness training.
Manufacturing Associate/ Senior Bioprocess Associate
Aerotek/Emergent BioSolutions
03.2019 - 06.2021
- Led and managed cross-functional deviation investigations including root cause analysis and product impact assessment using input from various departments with on-time closure to ensure product batch release
- Developed corrective action and preventive actions (CAPAs) to reduce deviation recurrence
- Authored and executed Change Controls
- Revised, authored, and managed manufacturing documents such as Batch Production Records and SOPs
- Assisted in activities related to other onsite departments such as the execution of validation protocols and tech transfer projects
- Performed aseptic filling operations and environmental monitoring/sampling inside various isolators
- Executed daily tasks such as cleaning and sterilizing equipment and filling components for use in production operations
- Adhered to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP)
- Recorded activities in production batch records and equipment logbooks
- Reviewed documentation and checked all calculations
- Complied with all applicable health, safety and environmental policies while working in controlled environment (ISO 1- ISO 9).
Technical Writer
SELF DECODE And LAB TEST ANALYZER
09.2016 - 02.2019
- Analyzed genomic and blood biomarker data for disease risk assessment
- Conducted literature reviews and synthesized epidemiological and clinical data to produce short- and long-term nutritional and lifestyle recommendations for health improvement
- Collaborated with project managers, developers, and science team members to develop project strategies and project plan (timelines, milestones, issues, risks, and actions)
- Wrote manuals and guides to streamline research and writing processes
- Reviewed and edited software documentation for spelling, grammar, punctuation, clarity, and accuracy
- Researched, wrote, and revised scientific articles to communicate research findings and developments to a wide range of audiences.
Physiology Lab Assistant
University of Colorado Boulder
07.2015 - 12.2015
- Performed routine laboratory maintenance tasks (glassware, lab bench and equipment) to maintain a well-organized and well-run laboratory
- Adhered to quality control protocols and lab safety regulations
- Prepared reagents and media according to prescribed procedures
- Preformed standard laboratory techniques (micro pipetting, metrology)
- Properly calibrated and repaired malfunctioning equipment to ensure precise results
- Managed specimen sample handling, receiving, storage and inventory
- Prepared samples for shipping and disposed of waste in proper containers.
Education
Bachelor of Science - Biochemistry
University of Colorado At Boulder
Boulder, CO05.2016
Bachelor of Science - Integrative Physiology
University of Colorado At Boulder
Boulder, CO05.2016
Skills
- Biomanufacturing
- Technical writing: SOPs, BPRs, Change Controls, CAPAs, Deviations, Protocols
- Quality Systems: SAP, Veeva, Audit Utopia
- Fill Finish Aseptic Processing/Manufacturing
- Project management
- cGMP and GDP
- Operational excellence
- Supplier Quality Management
- 21 CFR
- ISO Standards
- Software: WordPress, Lab Chart, R commander, MATLab, Microsoft office software, Adobe Acrobat
- Laboratory: Aseptic technique and cell culture, Solution preparation and dilution, Media preparation, Molecular cloning (recombinant DNA), Cell fractionation, DNA-based assays (PCR-RFLP), Protein based assays (HPLC, IEC, gel electrophoresis, ELISAs, Western Blotting, Bradford assay), UV-visible and fluorescence spectroscopy, Environmental monitoring
Timeline
Quality Systems Specialist I
Emergent BioSolutions
06.2023 - Current
Analyst II/III
Emergent BioSolutions
06.2021 - Current
Manufacturing Associate/ Senior Bioprocess Associate
Aerotek/Emergent BioSolutions
03.2019 - 06.2021
Technical Writer
SELF DECODE And LAB TEST ANALYZER
09.2016 - 02.2019
Physiology Lab Assistant
University of Colorado Boulder
07.2015 - 12.2015
Bachelor of Science - Biochemistry
University of Colorado At Boulder
Bachelor of Science - Integrative Physiology
University of Colorado At Boulder
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