Andrew Harrell
Kokomo
Summary
Quality management professional with a history of driving process improvements and ensuring compliance with stringent quality standards. Proven ability to collaborate effectively with cross-functional teams and achieve significant results. Known for reliability and adaptability in dynamic environments, with strong skills in quality assurance, process optimization, training and development of employees.
Overview
25
25
years of professional experience
Work History
Quality Manager
Biolife Plasma Services
09.2006 - 04.2025
- Oversight of regulatory compliance, quality standards, medical team and technicians, equipment maintenance and standardization as well as training.
- Facilitated regulatory inspections including FDA, AGES (EMA), State Health Department, CLIA, and IQPP.
- Trained, developed and mentored Quality Managers and Quality Technicians.
- Responsible for risk assessment and continuous improvement through performance of internal audits, process confirmation, the DMAIC process, and development of CAPAs.
- Collaborated with corporate partners in developing and streamlining SOPs.
- Responsible for numerous process improvements regarding quality, operations and employee safety.
- Enabled the Kokomo Facility to obtain numerous "Quality Excellence Awards" and the "Murray Thelin Award", which recognizes the top performing facility in the company.
Operations Supervisor / Training Specialist
Roche Diagnostics Corporation
11.1999 - 08.2006
- Supervised 3 departments simultaneously while meeting or exceeding productivity standards
- Ensured compliance with regulatory agencies, company policies, safety and environmental standards.
- Participated on a cross functional continuous improvement team, addressing efficiency and compliance.
- Conducted regular performance evaluations for direct reports.
- Developed and delivered training programs for operational efficiency, quality, compliance, communication and supervisory skills.
- Evaluated vendors and assisted in acquiring services and materials.
- Assisted in hosting customer and regulatory audits and inspections.
Education
Bachelor of Science - Communication
Indiana University
Indiana05-1991
Skills
- Internal Auditing
- Quality Management Systems
- Corrective and Preventative Actions
- Regulatory Compliance
- SOP Development
- Continuous Improvement
- Team Training and Development
- Operational Excellence
- Employee Coaching and Mentoring
Timeline
Quality Manager
Biolife Plasma Services
09.2006 - 04.2025
Operations Supervisor / Training Specialist
Roche Diagnostics Corporation
11.1999 - 08.2006
Bachelor of Science - Communication
Indiana University
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