MacKenzie Hall
Summary
Motivated professional looking to build relationships with customers and have more hands-on experience delivering Quality products.
Over 11 years in pharmaceutical manufacturing developing many skills suitable for any industry.
I'm known for remarkable productivity and efficient task completion. Skilled in regulatory compliance, process improvement, and risk management. Strong problem-solving skills combined with team collaboration and adaptability to consistently meet goals and milestones.
Overview
19
19
years of professional experience
Work History
Sr. Quality Associate
Takeda Pharmaceuticals
Social Circle, Georgia
12.2023 - 04.2026
- Lead/ Process Owner Product Quality Review (PQR)
- Lead/ Process Owner Gap Assessment Process
- Quality System Admin (Veeva Vault)
- Facilitated Classroom Instructor-Led Trainings (GMP refresher, Gap Assessment Process, and PQR Process)
- Performance team tracking to ensure timeliness and millstones are met
- Action Owner supporting Corrective Action Preventive Action (CAPA) (Problem Solving)
- Participated in Compliance Walks to assess adherence to quality standards and identify areas for improvement
- Qualified Self Inspection Co Auditor
- Create timelines and milestone goals to ensure work efficiency
- Work directly with Global and Site leadership
- Communicate ideas working towards process improvements and work efficiencies
Quality Associate II
Takeda Pharmaceuticals
Social Circle, Georgia
03.2017 - 12.2023
- Quality System (Veeva) Admin
- Co Lead on Site Product Quality Review (PQR) Process
- Create/ Revise and Approve standard operating procedures and Training Materials to ensure smooth operations
- Support FDA and Internal inspections
- Organize and host working meetings to ensure due dates and process expectations
- Site coordinator/ Point of Contact for Global procedure changes (Gap Assessment Process)
- Facilitated instructor-led training (ILT) sessions to onboard new members
- Co-lead for Return to Service (RTS) activities after site wide shutdown
- Work directly with site Leadership to effectively meet milestones
- Manufacturing rotation for personal development
Quality Documentation Specialist
Takeda Pharmaceuticals
Social Circle, Georgia
07.2014 - 03.2017
- Assisted in the development, implementation, and maintenance of document control systems.
- Facilitated communication between departments regarding documentation updates and changes.
- Assisted in preparing materials for regulatory inspections and audits.
- Audited quality documents to identify discrepancies and recommend improvements.
Bartender/Restaurant Server
Amici Covington
Covington, USA
10.2007 - 07.2014
- Greeted customers, delivering personalized service to enhance dining experience.
- Provided menu recommendations and answered questions regarding food ingredients and preparation methods.
- Executed opening and closing checklists, ensuring seamless restaurant operations and readiness.
- Handled cash transactions accurately while processing payments promptly.
- Managed inventory levels, restocking supplies to meet demand.
- Ensured compliance with health and safety regulations.
Education
Bachelor of Business Administration - Sales
Georgia State University, J. Mack Robinson College of Business
Atlanta, GA05-2014
Associates of Business Administration -
Georgia Perimeter College
Covington, GA07-2009
Skills
- Team collaboration
- Customer focus
- Problem solving
- Time management
- Leadership skills
- Project Management
- Performance monitoring
- GMP compliance
- Quality management systems
- Veeva Vault
- TrackWise
- Microsoft Office Suite
- ClipChamp
Timeline
Sr. Quality Associate
Takeda Pharmaceuticals
12.2023 - 04.2026
Quality Associate II
Takeda Pharmaceuticals
03.2017 - 12.2023
Quality Documentation Specialist
Takeda Pharmaceuticals
07.2014 - 03.2017
Bartender/Restaurant Server
Amici Covington
10.2007 - 07.2014
Bachelor of Business Administration - Sales
Georgia State University, J. Mack Robinson College of Business
Associates of Business Administration -
Georgia Perimeter College