Quality Lead

About BioLife Plasma Services Every day at BioLife we help 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. Role Purpose Monitors designated systems and activities, according to tasks trained and assigned, to ensure source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations. Works as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician. Responsibilities 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 and reports errors, deficiencies, discrepancies and observations to center management and the Quality Management Representative (QMR). Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Ensures SOPs are current and that staff perform routine tasks according to SOP through direct observation. In the absence of a QMR, works with the management team to prepare for and host internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations. Makes sure qualifications are maintained and performs all duties of Lead Technician. Maintains certification and performs all required duties for Medical History, Phlebotomy, and Sample Processing areas and trains new and existing staff. Qualifications 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) and 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. Supports the center management team in identifying operational opportunities for continuous improvement and initiating changes to center processes as needed. Education & Physical Requirements High School Diploma or equivalent required. Associate or Bachelor’s degree preferred. Work environment requires walking and standing all shift, frequent leaning, bending, stooping, crouching, and reaching. Must lift up to 26 lbs (occasionally 32–50 lbs). Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Must read and follow Standard Operating Procedures (SOPs) and maintain complete and accurate records. Due to potential exposure to blood‑borne pathogens (risk level 1), 90% of work tasks require prolonged glove wear. Compensation & Benefits Hourly wage range: $19.00 – $27.17, commensurate with experience. Eligible for short‑term incentives, 401(k) plan with matching, medical, dental, vision insurance, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, up to 80 hours of sick time, and up to 120 hours of paid vacation. Location USA – FL – Gainesville. 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