Radiopharmaceutical QC & Production Specialist III

SOFIE; Totowa (NJ); On-site; USD 80,000 - 85,000; Full time

Job summary

SOFIE in Totowa, NJ is seeking a QC/Production Associate III to operate radiosynthesizers and analytical equipment for drug product quality control. The role includes training responsibilities and ensuring cGMP documentation compliance.

Responsibilities cover synthesis, QC processes, calibration/qualification, inventory, safety, and cross-functional support within the Network Operations department. The position requires experience in radiopharmaceutical environments and the ability to work

Qualifications

• Requires 6+ years of radiopharmaceutical manufacturing and QC experience.
• Experience with FDG and NaF production and QC is preferred.
• Familiarity with cGMP documentation and ISO environment is expected.

Responsibilities

• Operate and maintain radiosynthesizers for drug product.
• Maintain QC equipment and ensure calibration/qualification before use.
• Perform training duties for QC/Production personnel as applicable.
• Complete cGMP documentation and investigations as required.
• Inventory management and material acceptance per SOPs.
• Assist with environmental monitoring and safety compliance.

Skills

Automation software

MS Office

Attention to detail

Team collaboration

Education

High school diploma

Associates degree in chemistry/engineering/natural sciences

Tools

Semi-preparative HPLC

Cyclotron control systems

Job description

SOFIE in Totowa, NJ is seeking a QC/Production Associate III to operate radiosynthesizers and analytical equipment for drug product quality control. The role includes training responsibilities and ensuring cGMP documentation compliance.

Responsibilities cover synthesis, QC processes, calibration/qualification, inventory, safety, and cross-functional support within the Network Operations department. The position requires experience in radiopharmaceutical environments and the ability to work