Latoya Morgan
Lansdowne,United States
Summary
Senior Quality Assurance with 19 years of extensive expertise in the biopharmaceutical sector. Demonstrates proficiency in CAPA analysis, batch record review, final product release, project management, standard operation procedure review, manufacturing support, process improvements and successful audits. Strong interpersonal and communication skills, ensuring compliance with FDA, EMA, and global standards.
Overview
13
13
years of professional experience
Work History
Senior Quality Assurance Specialist-Release
Iovance BiotheraupticS,Inc
Phila, United States
02.2024 - Current
- Review batch records and related production documentation, ensuring resolution of all identified issues prior to product disposition
- Support and review deviations, CAPAs, Laboratory Investigations, temperature excursions and other non-conformances
- Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release
- Collaborate with internal functions to address all identified issues in a timely manner
- Determine issues needed to be documented in the Quality System
- Coordinating release tasks as assigned to the Quality Release team
- Collaborate lot release dates with cross functional teams for clinical release and ensure timely lot closure
- Perform disposition of incoming materials and finished product
- Ensured compliance with current GMPs and facility procedures interface with functional groups, such as manufacturing, quality control and document control to determine events such as errors, deficiencies, discrepancies, deviations and other observations report
- Initiate and review of documentation for release, Issuance of labels, and miscellaneous duties
- Support generation of Quality Metrics
- Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations
Senior Quality Assurance Consultant
GlaxoSmithKline
King of Prussia, United States
03.2024 - 09.2024
- Implemented quality systems, resulting in measurable improvements in quality metrics
- Reviewed validation protocols via KNEAT systems, ensuring regulatory readiness
- Performed clinical batch reviews and releases, contributing to successful audits
- Identify efficiency opportunities while maintaining rigorous standards in pharmaceutical development
- Drive measurable improvements in quality metrics through strategic CAPA and risk assessment initiatives
- Champion continuous improvement culture by managing new team members and ensured they receive training to provide support, review and corrective action completed has needed prior to final batch release
- Mentor QA professionals, instilling forward-thinking approach to quality assurance in pharmaceutical development
- Spearhead QA initiatives, ensuring FDA/EMA compliance
- Drive clinical batch reviews and releases, contributing to successful audits
- Identify efficiency opportunities while maintaining rigorous standards in pharmaceutical development
- Collaborate with R&D and regulatory teams for seamless quality integration
Senior Quality Assurance- ExN (COE)
Organon-Merck
Plymouth Meeting, United States
10.2020 - 12.2023
- Promoted the development and implementation of strategic projects assuring compliance with established policies/procedures of the Division and Corporation and complies with all applicable Health Policy, governmental regulations Good Manufacturing Practice (GMP), both domestic and foreign
- Functioned objectively and/or within a team setting showing influence to facilitate enhancement of existing business processes, systems, identify risk and advance performance improvement activities
- Established new or improved processes, tools, and systems and drive consistent, standard business processes across External Quality Organization (EQA)
- Promoted the development, implementation, maintenance, and enhancement of critical processes, systems such as Quality Master Data, SAP, Supplier Transparency, Remediation, Global Change Management (GCM) within Trackwise and ETQ reliance management system
- Maintained and provides expertise on external systems, tools, data, and processes on an ongoing basis, specifically SAP via the use of specific T-Codes in SAP- including the troubleshooting of SAP issues and the building of new materials in SAP to promote ExN supply chain
- Provided ongoing systems Subject Matter Expert (SME) support ensuring ExN data and processes run smoothly with no interruption to supply for SAP systems
Quality Assurance Specialist- (Packaging OPERATIONS)
Merck
West Point, United States
06.2017 - 10.2020
- Performs packaging batch release for vaccine final package
- Collaborates with Planning, Operations and Technology organizations to ensure batches release by target due date
- Assists in sending samples and lab reagents to regulatory agencies
- Completes Batch record review and required SAP transactions for product release in SAP
- Performs 100% audit of process documents, logbooks and elogs to ensure completeness and accuracy for Packaging department
- Certified Shop Floor Auditor- performs GMP walk- through inspections, within Packaging operation department, to ensure compliance with GMP and regulatory requirements
- Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material as required
- Actively participates in the Tier process and uses this forum to escalate concerns and best practices while collaborating with Packaging operation team members in the identification and implementation of continuous improvement initiatives and action plans
- Collaborates with Packaging Operation team members to investigate deviations on the production floor
- Provide support of RMT for all agency inspections for West Point packaging operations
Quality Associate Specialist- Sterile Filling Operations
Merck
West Point, United States
03.2012 - 06.2017
- Perform batch record review for vaccines lyophilization and inspections
- Collaborates with personnel in Operations, Technology, and Planning to resolve issues, support investigation completion and provide recommended production dispositions and corrective actions where appropriate
- Provides direct quality support to ensure all areas follow federal regulation and to ensure activities are completed according to Standard Operating Procedures (SOP)
- Collaborates with production team members to identify and implement continuous improvement initiatives and action plans thus delivering right first-time manufacturing documentation
- Performs real-time shop floor, compliance, and aseptic behavior audits to ensure shop floor compliance
- Review of environmental testing associated with batch manufacture
Education
Graduate Course Work - Physician Assistant
Drexel University
Philadelphia, PA01.2002
BS - Food and Agricultural Science/Biology
University of Maryland Eastern Shore
Princess Anne, MD01.2001
Skills
- CAPA analysis
- Batch record review
- Audit
- Project management
- SOP review
- Manufacturing support
- Risk assessment
- Change control
- Master Data
- Interpersonal skills
- Communication skills
Awards
- Alliance Minority Participation Honors Academic Scholarship
- Pennsylvania Literacy Corps Volunteer Award
- Johnson & Johnson Ward of Excellence for Project management
- Merck inspired Award for Leadership
- Merck Award of Excellence for Project management
- Organon recognition Award for Project management
Timeline
Senior Quality Assurance Consultant
GlaxoSmithKline
03.2024 - 09.2024
Senior Quality Assurance Specialist-Release
Iovance BiotheraupticS,Inc
02.2024 - Current
Senior Quality Assurance- ExN (COE)
Organon-Merck
10.2020 - 12.2023
Quality Assurance Specialist- (Packaging OPERATIONS)
Merck
06.2017 - 10.2020
Quality Associate Specialist- Sterile Filling Operations
Merck
03.2012 - 06.2017
Graduate Course Work - Physician Assistant
Drexel University
BS - Food and Agricultural Science/Biology
University of Maryland Eastern Shore
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