Quality Lead

BioLife Plasma Services; Gainesville (FL); On-site; USD 26,174 - 37,429; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid vacation

Tuition reimbursement

Sick time and volunteer time off

Job summary

BioLife Plasma Services is seeking a Quality Lead Technician in Gainesville, Florida. This role involves ensuring compliance with Good Manufacturing Practices and leading quality assurance initiatives.

The ideal candidate will have relevant industry experience, certifications in Medical History, Phlebotomy, and Sample Processing, and strong problem-solving skills. The position offers a competitive hourly wage and comprehensive benefits including medical coverage and paid vacation.

Qualifications

• Minimum of one year of relevant work experience in a regulated industry.
• Certification in Medical History, Phlebotomy, and Sample Processing.
• Understanding of quality assurance in an FDA-regulated environment.

Responsibilities

• Review operational records to ensure compliance with cGMP.
• Conduct monthly quality assurance audits and maintain SOPs.
• Train new and existing staff in quality assurance practices.

Skills

Effective communication

Organizational skills

Technical problem-solving

Ability to read SOPs

Education

High School Diploma or equivalent

Associate or Bachelor’s degree

Job description

Job Description

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. This position serves as a Quality Lead Technician responsible for ensuring all source plasma manufacturing activities comply with current Good Manufacturing Practices (cGMP), the Shire Quality System, and applicable regulations.

Key Responsibilities

• Perform duties associated with Quality (50%) including reviewing operational records, ensuring completeness, accuracy, and compliance with cGMP.
• Track deviations in operating procedures and policies; 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, plasma collection, sample collection, storage, product release, quality assurance, 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; assist in timely closure of observations.
• Maintain qualifications and perform all duties in Medical History, Phlebotomy, and Sample Processing areas; train new and existing staff through demonstration, instruction, observation, and feedback (30%).
• Provide leadership and training assistance in support of center management and the supervisory team, including oversight of operational flow (10%).
• Maintain certifications and perform all required duties of Lead Technician (10%).
• Lead and support continuous improvement initiatives using tools such as 5S, Value Stream Mapping, and Kaizen.

Qualifications

• A minimum of one year of relevant work experience in a regulated industry or an equivalent combination of education and experience.
• Certification in Medical History, Phlebotomy, and Sample Processing at the plasma center.
• 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.
• Ability to read and follow Standard Operating Procedures (SOPs) and maintain complete and accurate records.

Physical Requirements

• Must walk and stand for the entire work shift; frequent leaning, bending, stooping, crouching, and reaching above shoulders and below knees.
• Requires frequent lifting up to 26 lbs.; occasional lifting of materials 32–50 lbs.
• Requires fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
• Due to potential exposure to blood borne pathogens (risk level 1), 90% of tasks require prolonged glove wear.

Education

• Essential: High School Diploma or equivalent.
• Desired: Associate or Bachelor’s degree.

Compensation & Benefits

Hourly wage range: $19.00 – $27.17 USD. Compensation may vary based on qualifications, experience, certifications, and location. Eligible U.S. employees may receive short‑term incentives, medical, dental, vision, 401(k) with company match, short‑ and long‑term disability, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, 80 hours of sick time per calendar year, and up to 120 hours of paid vacation for new hires.

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.

Employment Details

Location: USA – FL – Gainesville
Employer: BioLife Plasma Services (Takeda subsidiary)
Worker type: Employee
Worker sub‑type: Regular
Time type: Full time
Classification: Non‑Exempt
Job Exempt: No