Quality Lead Technician

Responsibilities

• Review operational records to ensure they are complete, accurate, and compliant with cGMP requirements.
• Track deviations in operating procedures and report errors, deficiencies, or discrepancies to management.
• Conduct monthly quality assurance audits for critical control points, including donor suitability, plasma collection, and sample processing.
• Ensure staff perform routine tasks according to Standard Operating Procedures (SOPs) through direct observation.
• Maintain qualifications and perform all technical duties in Medical History, Phlebotomy, and Sample Processing areas.
• Provide leadership and training to new and existing staff through demonstration, instruction, and feedback.
• Assist management in preparing for internal audits and external inspections.

Requirements

• High School Diploma or equivalent.
• Minimum of one year of relevant work experience, preferably in a regulated industry.
• Certification in Medical History, Phlebotomy, and Sample Processing.
• Demonstrated understanding of quality assurance in an FDA-regulated environment.
• Ability to stand for entire work shifts and perform physical tasks including lifting up to 50 lbs.

Preferred Qualifications

• Associate or Bachelor’s degree.
• Experience with continuous improvement methodologies such as 5S, Value Stream Mapping, or Kaizen.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off and paid vacation.

About the Company

Takeda is an industry-leading, global pharmaceutical company dedicated to putting patients at the center of everything we do. Through our subsidiary, BioLife Plasma Services, we work to improve the lives of patients with rare diseases by providing high-quality plasma manufacturing and collection services.