Jacqueline Brown

Twenty-one years of experience in IT Quality system-related roles at Baxter as both employee and contractor.

• Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
• Updated quality assurance standard operating procedures to meet compliance requirements
• Evaluated quality problems and performed assessments to identify and resolve issues.
• Improved quality processes for increased efficiency and effectiveness.
• Coordinated and oversaw application periodic reviews to evaluate on-going product quality and safety and address non-conformances.
• Mentored and encouraged employees to strive for excellence while fostering professional growth.
• Provided guidance to internal stakeholders on quality and compliance requirements, ensuring governance, awareness, and understanding across the organization
• Performed regular compliance reviews and audits, identifying non-compliance issues.
• Analyzed and identified risk areas to determine compliance with applicable laws and regulations.
• Prepared and presented comprehensive reports to upper management and audit team, covering issues and recommendations
• Addressed compliance issues by developing and implementing non conformance reports, root cause analysis and corrective action plans (CAPAs); participated in FDA Audits.
• Contributed to continuous improvement initiatives and projects to enhance quality and compliance processes and drive operational excellence
• Consulted on periodic reviews, business continuity plans and strict adherence to change management
• Improved vendor performance by 45% by implementing vendor practices surrounding release management, validation testing and practices, operations review and disaster recovery requirements
• Strategized concurrent validation activities across enterprise platform projects, ensuring successful implementations
• Managed project validation teams consisting of 2 to 43 members. Managed project schedules, budgets from $20,000 to $300,000, and project deliverables; led validation and test teams throughout the Software Development Lifecycle
• Managed System Integration (end to end), User Acceptance & Regression Testing teams for all validation activities; led all validation activities including Installation Qualification, Operational Qualification, Performance Qualification creation & execution, risk management assessment and defect management
• Established and tracked quality department goals and objectives
• Skilled at working independently and collaboratively in team environment
• Self-motivated, with strong sense of personal responsibility
• Proven ability to learn quickly and adapt to new situations
• Worked well in team setting, providing support and guidance
• Worked effectively in fast-paced environments

Global IT Compliance and Validation Manager for:

• Serialization (Optel & Systech, IRIS, rfxcel rTS, DCLink, FMLogistics) Quality Compliance Manager and Validation Manager
• Global Laboratory Information Management System (LabVantage LIMS & SQL
• LIMS) Validation Manager
• Learning Management System (CSOD) Validation Manager
• Global Product Authentication and Labeling Program Validation Manager
• Adverse Event Reporting System (AERS) Quality Compliance Analyst
• Global Bio Life Plasma and Bio Science Polymerase Chain Reaction (PCR) System (Sanguin) Validation Manager

• Created adherence procedures regarding 21CFR Part 11 Electronic Records and Signatures for Quality Department
• Documented entire validation process, noting changes or alterations completed.
• Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
• Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity and other factors.
• Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines
• Generated validation plans for Pharmacia Sales Force projects, setting specific temporal and budgetary goals for development and delivery
• Authored validation protocols for Sales Force systems, verifying compliance with internal policies related to controlled drug procurement
• Produced and maintained technical documentation for project reference.
• Proposed development and testing improvements to positively impact usability, function and performance.
• Developed validation master plans, process flow diagrams and standard operating procedures.
• Collaborated with cross-functional teams for identification and resolution of validation issues.
• Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
• Worked with stakeholders and team members on quality assurance efforts for hardware components.
• Met tight deadlines to satisfy client demands and project timelines.

• Achieved financial objectives by preparing quality assurance project budgets up to $425,000, scheduling expenditures, analyzing variances, and initiating corrective actions
• Authored documentation for internal use by QA personnel, setting guidelines for review activities and reporting requirements
• Maintained product quality by enforcing adherence to varying industry government regulated requirements
• Prepared process quality reports by collecting, analyzing, and summarizing information and trends
• Developed quality assurance staff of 17 analysts, by recruiting, selecting, orienting, and training employees; coached, counseled, and addressed employees’ weaknesses