Takeda
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Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services. 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. Objectives / Purpose
Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to cGMP, the Shire Quality System, and other applicable regulations for a plasma center. Serves as Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician. All responsibilities are to be completed in compliance with federal, state, local and company-specific regulations related to quality, safety, and day‑to‑day activities. Maintain complete and accurate records in accordance with cGMP. Accountabilities
Performs duties associated with Quality (including but not limited to): 50% of time. Reviews operational records to ensure completeness, accuracy and compliance with cGMP. Tracks deviations and reports errors, deficiencies, discrepancies and observations to center management and QMR. Conducts monthly quality assurance audits for critical control points and key elements for donor suitability, plasma collection, sample collection, plasma storage, product release, QA, and training programs. Ensures SOPs are current and staff perform tasks according to SOPs through direct observation. In the absence of a QMR, collaborates with management to prepare for and host internal auditors and external inspectors; assists center management to ensure timely closure of observations. Maintains qualifications and performs duties in 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 support for center management and supervisory teams, including oversight of operational flow. Maintains certification and performs all required duties of Lead Technician. Dimensions & Aspects
Technical/Functional: Minimum one year of relevant work experience, preferably in a regulated industry, or equivalent education/experience. Certification in Medical History, Phlebotomy, and Processing Technician areas. Completion of Lead Technician training. Understanding of QA in an FDA-regulated environment. Strong communication, organizational, and technical/problem-solving skills. Supports operational improvements using approved procedures (e.g., 5S, Value Stream Mapping, Kaizen). Maintains cleanliness and accurate records. Ability to read and follow SOPs. Leadership, Integrity, Fairness, Honesty, Perseverance, Patient-centric mindset, Building trust, Reinforcing reputation, Developing the business. Decision-making & Autonomy: Seeks guidance from Center Manager for complex decisions; escalates donor/employee concerns to management. Interaction: Provides exceptional service to donors and staff. Attends meetings. Strong verbal communication and teamwork. Innovation: Coordinates with center roles to problem‑solve and ensure safety and a great customer experience. Complexity: Production environment requiring standing for long periods; frequent bending, stooping, reaching; lift requirements up to 50 lbs; PPE and exposure considerations for blood-borne pathogens. Education, Behavioral Competencies & Skills
Essential: High School Diploma or equivalent. 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
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and strive to be more transparent with our pay practices. Location:
USA - IL - Fairview Heights U.S. Hourly Wage Range:
$19.00 - $26.13 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on qualifications, experience, skills, and location. The actual wage will comply with state/local minimum wage requirements. U.S. based employees may be eligible for short-term incentives and a benefits package including medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, holidays, and well-being benefits. New hires may accrue vacation and sick time per policy. EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected veteran status in accordance with applicable laws. Locations : USA - IL - Fairview Heights Worker Type : Employee Worker Sub-Type : Regular Time Type : Full time Job Exempt : No
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Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services. 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. Objectives / Purpose
Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to cGMP, the Shire Quality System, and other applicable regulations for a plasma center. Serves as Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician. All responsibilities are to be completed in compliance with federal, state, local and company-specific regulations related to quality, safety, and day‑to‑day activities. Maintain complete and accurate records in accordance with cGMP. Accountabilities
Performs duties associated with Quality (including but not limited to): 50% of time. Reviews operational records to ensure completeness, accuracy and compliance with cGMP. Tracks deviations and reports errors, deficiencies, discrepancies and observations to center management and QMR. Conducts monthly quality assurance audits for critical control points and key elements for donor suitability, plasma collection, sample collection, plasma storage, product release, QA, and training programs. Ensures SOPs are current and staff perform tasks according to SOPs through direct observation. In the absence of a QMR, collaborates with management to prepare for and host internal auditors and external inspectors; assists center management to ensure timely closure of observations. Maintains qualifications and performs duties in 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 support for center management and supervisory teams, including oversight of operational flow. Maintains certification and performs all required duties of Lead Technician. Dimensions & Aspects
Technical/Functional: Minimum one year of relevant work experience, preferably in a regulated industry, or equivalent education/experience. Certification in Medical History, Phlebotomy, and Processing Technician areas. Completion of Lead Technician training. Understanding of QA in an FDA-regulated environment. Strong communication, organizational, and technical/problem-solving skills. Supports operational improvements using approved procedures (e.g., 5S, Value Stream Mapping, Kaizen). Maintains cleanliness and accurate records. Ability to read and follow SOPs. Leadership, Integrity, Fairness, Honesty, Perseverance, Patient-centric mindset, Building trust, Reinforcing reputation, Developing the business. Decision-making & Autonomy: Seeks guidance from Center Manager for complex decisions; escalates donor/employee concerns to management. Interaction: Provides exceptional service to donors and staff. Attends meetings. Strong verbal communication and teamwork. Innovation: Coordinates with center roles to problem‑solve and ensure safety and a great customer experience. Complexity: Production environment requiring standing for long periods; frequent bending, stooping, reaching; lift requirements up to 50 lbs; PPE and exposure considerations for blood-borne pathogens. Education, Behavioral Competencies & Skills
Essential: High School Diploma or equivalent. 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
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and strive to be more transparent with our pay practices. Location:
USA - IL - Fairview Heights U.S. Hourly Wage Range:
$19.00 - $26.13 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on qualifications, experience, skills, and location. The actual wage will comply with state/local minimum wage requirements. U.S. based employees may be eligible for short-term incentives and a benefits package including medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, holidays, and well-being benefits. New hires may accrue vacation and sick time per policy. EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected veteran status in accordance with applicable laws. Locations : USA - IL - Fairview Heights Worker Type : Employee Worker Sub-Type : Regular Time Type : Full time Job Exempt : No
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