Quality Lead Technician

Job Description 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 role is responsible for ensuring source plasma manufacturing complies with Good Manufacturing Practices (cGMP), the Shire Quality System, and all applicable regulations. As a Lead Technician (or Center Supervisor by exception) the candidate will perform technical tasks, lead quality activities, train staff, and ensure continuous improvement. Responsibilities Review operational records to ensure completeness, accuracy, and cGMP compliance (50%). Track deviations in operating procedures and policies, reporting deficiencies and observations to center management and the Quality Management Representative (QMR). Conduct monthly quality assurance audits for critical control points and key elements related to donor suitability, source plasma collection, sample collection, plasma storage, product release, and employee training. Ensure SOPs are current and staff perform routine tasks according to SOP through direct observation. Collaborate with management to prepare for and host internal auditors and external inspectors, and assist in timely closure of observations. Maintain qualifications and perform core and elective duties for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback (30%). Provide leadership and training assistance to the center management and supervisory team, including oversight of operational flow (10%). Maintain certification and perform all required duties of Lead Technician (10%). Qualifications High School Diploma or equivalent (required). Associate or Bachelor’s degree preferred. Minimum of one year of relevant regulated industry experience or equivalent education and experience. Certification in Medical Historian, Phlebotomy, and Processing Technician. Completion of all training through Lead Technician level. 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 maintain complete, accurate records. Cleanliness of work area and support of general workplace hygiene. Ability to multi‑task, work as a team player, and provide exceptional customer service to donors and staff. Physical ability to walk, stand, lean, bend, stoop, crouch, reach, and lift up to 50 lbs, with prolonged glove wear required for 90% of tasks. Soft competencies: leadership, integrity, fairness, honesty, perseverance, patient‑centered focus, trust building with society, reputation reinforcement, and business development. Compensation and Benefits U.S. Hourly Wage Range: $19.00 – $27.17. Salary is based on qualifications, experience, skills, certifications, and location. Eligible U.S. employees may receive medical, dental, vision, 401(k) with company match, short‑ and long‑term disability, life insurance, tuition reimbursement, paid volunteer time, company holidays, well‑being benefits, up to 120 hours paid vacation, and up to 80 hours sick time per year. Locations USA – AL – Birmingham EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. #J-18808-Ljbffr