Quality Lead Technician responsible for ensuring source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations. Monitors designated systems and activities, conducts monthly quality assurance audits, and trains new and existing staff on donor center procedures.
Requirements
- Minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience.
- Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician).
- Completion of all training through Lead Technician.
- Demonstrated understanding of quality assurance in an FDA-regulated environment.
- Effective communication, organizational, and technical/problem-solving skills.
Benefits
- Medical, dental, vision insurance
- 401(k) plan and company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits