Quality Lead

Job Description About Bio Life Plasma Services

Every day at Bio Life, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast‑paced, friendly environment.

Bio Life Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician.

• (50%) Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements.
• Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR).