Quality Lead Technician

Takeda

124d • $20 - $27

About The Position

Every day at BioLife, 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. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. The position involves monitoring designated systems and activities 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. The role includes performing technical tasks as a Lead Technician and ensuring compliance with federal, state, local, and company-specific regulations related to quality, safety, and performance.

Requirements

• A minimum of one year of relevant work experience, preferably in a regulated industry.
• 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.

Nice To Haves

• Associate or Bachelor’s degree preferred.

Responsibilities

• Reviews operational records to ensure they are complete, accurate, and compliant with cGMP requirements.
• Tracks deviations in operating procedures and policies and reports errors, deficiencies, discrepancies, and observations to management.
• Conducts monthly quality assurance audits for critical control points and key elements related to donor suitability and plasma collection.
• Ensures SOPs are current and that staff perform routine tasks according to SOP through direct observation.
• Assists management teams to ensure timely closure of observations.
• Maintains qualifications and performs all duties for Medical History, Phlebotomy, and Sample Processing areas.
• Trains new and existing staff on donor center procedures.
• Provides leadership and training assistance in support of center management.
• Maintains certification and performs all required duties of Lead Technician.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per year.
• Accrual of up to 120 hours of paid vacation for new hires.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees