Radiopharmaceutical QC Validation Specialist

LE006 BAMF Health Management, LLC; Grand Rapids (MN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Employer paid High Deductible Health计划

Flexible Vacation Time

401(k) Retirement Plan with generous (

Free Grand Rapids downtown parking

Job summary

BAMF Health is seeking a QC Validation Specialist to collaborate with operations, quality, regulatory, engineering, and chemistry teams in a rapidly evolving radiopharmaceutical setting. You will support technology transfer, validation activities, and documentation generation to ensure compliant product qualification.

Primary duties include performing HPLC/GC/TLC analyses, managing deviations, and training staff during tech transfer while maintaining GMP standards in a Grand Rapids facility.

Qualifications

• Bachelor's degree in applied science or equivalent is required.
• At least 2 years’ hands-on GMP experience with analytical equipment in pharma/biotech.
• Familiarity with CDMO/CMO work and traditional chromatography instrumentation.

Responsibilities

• Develop study protocols and documentation for tech transfer and product qualification.
• Perform testing for process qualification and method validation per SOPs.
• Oversee equipment and QC systems qualification and cleaning verification.
• Lead deviation/investigation management during tech transfer.
• Train Radiopharmacy personnel on new testing procedures and maintain equipment.

Skills

Analytical equipment experience

GMP environment familiarity

Technology transfer experience

Education

Bachelor's degree in Applied Science

Tools

HPLC

GC

TLC

HPGe

Job description

BAMF Health is seeking a QC Validation Specialist to collaborate with operations, quality, regulatory, engineering, and chemistry teams in a rapidly evolving radiopharmaceutical setting. You will support technology transfer, validation activities, and documentation generation to ensure compliant product qualification.

Primary duties include performing HPLC/GC/TLC analyses, managing deviations, and training staff during tech transfer while maintaining GMP standards in a Grand Rapids facility.