Paula Boone
Sims,NC
Summary
Dynamic Senior Supervisor with significant expertise at Biogen in quality assessment and regulatory compliance. Proven track record of leading QA projects that enhance cGMP systems, driving operational efficiency improvements. Skilled in deviation management and data review processes, ensuring timely batch approvals in high-pressure environments. Dedicated to team development and implementing continuous improvement initiatives.
Overview
3
3
years of professional experience
Work History
Senior Supervisor, PF QA Shop Floor
Biogen
Research Triangle Park, NC
02.2022 - Current
- Coordinate shift personnel to ensure real-time, on-the-floor batch reviews, and assessment of batch acceptance for clinical and commercial production batches.
- Supervise quality management projects, including oversight of team members.
- Responds to the operational needs of the DP Parenteral Facility, tracks and monitors gap-proposed solutions to QA Management, and recommends changes to cGMP systems.
- Ensure on-time review and approval of exceptions to closure.
- Assist and manage the development of the QA Shop Floor personnel, evaluation, scheduling, and balancing of departmental workload.
- Provide mentorship within and across production functions.
- Coordinate and support daily activities as they relate to the manufacturing/QA shop floor.
Education
Bachelor of Arts - Business Administration
Strayer University
Raleigh, NC05-2011
Skills
- Quality Assessment Skills
- Regulatory compliance
- Data Review Process
- Deviation management
- Team Leadership
- Understanding of cGMP Regulations
Timeline
Senior Supervisor, PF QA Shop Floor
Biogen
02.2022 - Current
Bachelor of Arts - Business Administration
Strayer University
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