Quality Assurance Coordinator - Lab Compliance

Biolife Plasma Services; Bostwick (GA); On-site; USD 26,000 - 41,000; Full time

Job summary

BioLife Plasma Services, a Takeda subsidiary, seeks a QA professional in Georgia to oversee lab testing quality assurance. The role emphasizes compliance with CFRs, GMPs, and QA procedures, with responsibilities including review of QC data and corrective actions.

The position supports BioLife’s mission to ensure high-quality plasma testing for patient care. The candidate should hold a biomedical degree (or higher) and have at least two years in lab services, with MT/MLT certification preferred.

Qualifications

• Bachelor's degree or higher in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology).
• Minimum of two years' experience in a professional or technical capacity in laboratory services, blood services, quality, or pharmaceutical manufacturing.
• Technical/Professional certification preferred; MT or MLT certification preferred.

Responsibilities

• Review testing, quality control, and other testing reports for accuracy and compliance to cGMP requirements.
• Identify problems that may adversely affect test performance or reporting and notify management.
• Adheres to laboratory quality control policies and documents calibrations and maintenance.
• Participates in operational excellence initiatives (5S, Value Stream Mapping, Kaizen).

Skills

Regulatory knowledge

Two years experience

Education

Bachelor's degree in biomedical discipline

ASCP MT/MLT certification preferred

Job description

BioLife Plasma Services, a Takeda subsidiary, seeks a QA professional in Georgia to oversee lab testing quality assurance. The role emphasizes compliance with CFRs, GMPs, and QA procedures, with responsibilities including review of QC data and corrective actions.

The position supports BioLife’s mission to ensure high-quality plasma testing for patient care. The candidate should hold a biomedical degree (or higher) and have at least two years in lab services, with MT/MLT certification preferred.