Quality Lead Technician
$39,520–$56,514 year
On-siteAugusta, Georgia, United States
Job Summary
Monitor designated systems and activities to ensure source plasma manufacturing adheres to current Good Manufacturing Practices (cGMP) and the Shire Quality System. Review operational records for accuracy and compliance, track deviations, and report errors or deficiencies to management and the Quality Management Representative. Conduct monthly quality assurance audits for critical control points related to donor suitability, plasma collection, storage, and product release. Provide leadership and training assistance to staff on donor center procedures, while maintaining certifications in Medical History, Phlebotomy, and Sample Processing areas. This role supports BioLife Plasma Services, a subsidiary of Takeda, in improving patient lives with rare diseases.
Required 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)
- 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
- Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records
- Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance
- High School Diploma or equivalent
Desired Qualifications
- Associate or Bachelor's degree
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