Quality Lead Technician

BioLife Plasma Services • Waterloo, IA

108d • $19 - $26

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 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.

Requirements

• A 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.
• Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.

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 through established mechanisms.
• Reports errors, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR).
• Conducts monthly quality assurance audits for critical control points and key elements related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
• Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation.
• In the absence of a QMR, collaborates with the management team to prepare for and host internal auditors and external inspectors.
• Assists center 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 through demonstration, instruction, observation, and feedback.
• Provides leadership and training assistance in support of center management and supervisory team, including oversight of operational flow.
• Maintains certification and performs all required duties of Lead Technician.

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
• Up to 80 hours of sick time per calendar year
• Accrual of up to 120 hours of paid vacation for new hires

What This Job Offers

• Job Type: Full-time
• Industry: Ambulatory Health Care Services
• Education Level: High school or GED