Quality Lead Technician

Job Description BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. We provide a purpose-driven role in a fast-paced, friendly environment where you focus on donors while we support you with career growth and a comprehensive benefits program. Objectives / Purpose Monitor designated systems and activities, as trained and assigned, to ensure source plasma manufacturing is performed consistently with Good Manufacturing Practices (cGMP), the Shire Quality System, and other regulations for a plasma center. Serve as Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician. Accountabilities Review operational records to ensure they are complete, accurate, and compliant with cGMP requirements. Track deviations in operating procedures and policies through established mechanisms; report errors, deficiencies, discrepancies, 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, quality assurance, and employee training. Ensure SOPs are current and staff perform routine tasks according to SOP through direct observation. When QMR is absent, collaborate with the management team to prepare for and host internal auditors and external inspectors; assist center management teams to ensure 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. Provide leadership and training assistance to support center management and supervisory team, including oversight of operational flow. Maintain certification and perform all required duties of Lead Technician. Dimensions and Aspects A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience. Certification in Medical Historian, Phlebotomy, and Processing Technician. Completion of all training through Lead Technician and demonstrated understanding of quality assurance in an FDA-regulated environment. Effective communication, organizational, and technical/problem‑solving skills. Support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, using company‑approved procedures (including 5S, Value Stream Mapping, and Kaizen). Maintain general cleanliness of work area and assist other work areas as needed. Read and follow Standard Operating Procedures (SOPs) and maintain complete and accurate records. Leadership & Core Values Integrity, fairness, honesty, perseverance. Put patients at the center, build trust with society, reinforce reputation, develop business. Decision‑Making and Autonomy Refer to Center Manager for guidance on complex, medium‑impact or above decisions (internal). Refer to management team for escalated donor/employee concerns (internal). Interaction Provide exceptional customer service to donors and fellow employees. Attend staff meetings and other team meetings as required. Good verbal communication and customer service skills. Ability to multi‑task and work as a team player. Innovation Coordinate with all other center roles to problem‑solve, ensure safety of staff and donors, and provide an exceptional customer experience. Complexity Production environment requiring ability to walk and stand for the entire shift. Frequent leaning, bending, stooping, crouching, and reaching above shoulders and below knees. Frequent lifting up to 26 lbs; occasional lifting of materials 32–50 lbs. Fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Risk level 1 exposure to blood‑borne pathogens; 90% of tasks require prolonged glove wear. Education, Behavioral Competencies and Skills Essential: High School Diploma or equivalent required. Desired: Associate or Bachelor's degree preferred. Additional Information FLSA Classification (US) – Non‑Exempt. Other duties and responsibilities as assigned. BioLife Compensation and Benefits Summary U.S. Hourly Wage Range: $20.00 – $28.60. The actual wage offered may depend on qualifications, experience, skills, education, certifications, and location. U.S. based employees may be eligible for short‑term incentives, medical, dental, vision, 401(k) plan and company match, short‑term and long‑term disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well‑being benefits. U.S. based employees are eligible for up to 80 hours of sick time and new hires accrue up to 120 hours of paid vacation. 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. Additional Details Location: USA – NC – Fayetteville – Morgan. Worker Type: Employee. Worker Sub‑Type: Regular. Time Type: Full time. Job Exempt: No. #J-18808-Ljbffr