Quality Assurance Coordinator, Lab Compliance

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

Job summary

BioLife Plasma Services, a Takeda subsidiary, seeks a QA professional to ensure laboratory testing quality and regulatory compliance. The role emphasizes adherence to cGMP, CFRs, and GMP practices within the BioLife Testing Laboratories’ framework.

The position focuses on quality assurance activities, maintaining QC policies, and supporting continuous improvement initiatives to uphold the highest testing standards for the plasma used in life-changing medicines.

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.
• MT or MLT certification from ASCP or other certifying organization preferred.

Responsibilities

• Reviews testing, quality control, and other testing reports for accuracy and compliance to cGMP requirements.
• Maintains familiarity with laboratory operating and quality assurance/control procedures and quality system processes.
• Adheres to laboratory quality control policies and documents QC activities, calibrations and maintenance.
• Identifies problems that may affect test performance and notifies management; follows corrective action policies when needed.
• Performs review and/or validation of SOPs as needed.
• Participates in operational excellence initiatives to drive continuous improvement.
• Other duties as assigned.

Skills

Communication skills

Attention to detail

Microsoft Office

Analytical thinking

Education

Bachelor's degree in biomedical discipline

Associate degree in laboratory science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

BioLife Plasma Services, a Takeda subsidiary, seeks a QA professional to ensure laboratory testing quality and regulatory compliance. The role emphasizes adherence to cGMP, CFRs, and GMP practices within the BioLife Testing Laboratories’ framework.

The position focuses on quality assurance activities, maintaining QC policies, and supporting continuous improvement initiatives to uphold the highest testing standards for the plasma used in life-changing medicines.