Quality Assurance Manager
Resume:
******@*****.***
Houston, Texas
linkedin.com/resumekraft
www.linkedin.com/in/harriso
n-butler-985997194
CONTACT
Six Sigma Black Belt
TrackWise Digital Quality
Management Software
Veeva Systems Software
RIKA Plasma Donation System
Internal Auditor
Statistical Analysis
Regulatory Compliance
Root Cause/Corrective Action
Phlebotomy/Apheresis
Technician
Process Improvement
Decision Analysis
Training/Mentoring
Quality Assurance
SKILLS
Texas Southern University
Bachelor of Business
Administration in
Management
1993-05-29
Texas School of Business
Certified Medical Assistant
1997-06-27
EDUCATION
Detail-oriented and assertive Quality Assurance Manager with 15+ years of experience in quality assurance, root cause analysis, and phlebotomy. Six Sigma Black Belt Certified and skilled in leading teams, developing programs, maintaining compliance with Current Good Manufacturing Practice (CGMP) and other regulatory authorities. Proven track record of improving compliance, reducing processing errors, and mentoring quality teams. SUMMARY
CSL Plasma
Quality Assurance Manager Sep 2020 - Aug 2024
Key Objectives:
Responsible for management and quality approval of deviations including system access.
Direct quality oversight and guidance on systemic deviations that may negatively affect product, donor and employee safety. Lead and function as the key quality representative for site supplier, customer and regulatory audits.
Manage audit outcomes through review of findings, coordination of remediation (CAPA) and successful closure of audits. Mentor and improve quality resource knowledge and skill sets. Knowledge of HR systems is advantageous, in particular Workday, Performance Management and Learning Management Systems (LMS). Accomplishments:
Changed the mindset of the Quality team from a reactive stance to proactive.
Restructured the roles of the Quality team in order to improve efficiency while our department was understaffed.
Investigated and identified root causes of process deficiencies, preventing recurrence in over 40% of cases.
Implemented a targeting training program for QA team members ensuring consistent knowledge of cGMP and other GxP documentation, achieving 100% team compliance.
Directly managed a team of 6 QA analysts, fostering a high-performance culture that resulted in a 15% reduction of processing errors. Gulf Coast Regional Blood Center
Training Coordinator Sep 2003 - Aug 2019
Key Objectives:
Direct quality oversight and guidance on systemic deviations that may negatively affect product, donor and employee safety. Provide targeted observations of classroom instruction and provide feedback and assistance to content coordinators to facilitate improvement and innovation.
EXPERIENCE
QUALITY ASSURANCE MANAGER/PROCESS IMPROVEMENT/GXP
STANDARDS
Harrison Butler
Provide targeted staff development in methods of integrating technology in the delivery of curriculum.
Assist in the development and implementation of a continuous evaluationof the instructional technology program and implement changes based on findings.
Developed and delivered educational workshops for over 400 employees, designed to defuse conflicts while improving work performance. Managed quality assurance by developing & revising Standard Operating Procedures (SOPs) and monitoring staff compliance regarding new standards & existing policies to ensure continuous improvement. Accomplishments:
Successfully led validation studies from concept to completion which resulted in a smooth transition to Rika Plasma Donation System. Implemented changes which streamlined screening process as well as decreased data entry errors.
Trained and mentored Quality Staff to prepare for internal compliance audits and methodologies on completing a successful project from conception to implementation.
Contact this candidate