QC Validation Specialist - Radiopharma GMP & Tech Transfer

LE006 BAMF Health Management, LLC; Grand Rapids (MI); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health plan with HSA

Flexible vacation

401(k) with employer match

Parking

Job summary

BAMF Health in Grand Rapids, MI is seeking a QC Validation Specialist to join our radiopharmacy and analytics teams. You will develop study protocols, perform method validation, and lead equipment qualification activities in a GMP environment.

The role partners with operations, quality, regulatory, engineering, and chemistry to transfer technology, control documentation, and ensure compliance with QMS and GMP standards.

Qualifications

• 2 years hands-on experience with analytical equipment in a GMP environment
• Familiarity with CDMO/CMO work
• Foundational expertise in setup, operation, and maintenance of conventional analytical instrumentation (HPLC/GC/TLC) and chromatography data systems
• Experience in method transfer of HPLC, TLC, or GC QC

Responsibilities

• Develop study protocols and controlled documentation for technology transfer and qualification of radiopharmaceutical products
• Perform testing activities for process qualification and method validation per protocols and SOPs; prepare study reports
• Oversee equipment qualification, computer system validation, and cleaning verification protocols
• Lead investigations and document deviations during technology transfer
• Train personnel on new testing procedures and provide ongoing production support
• Operate, maintain, and clean analytical testing equipment during technology transfer
• Collaborate with internal teams and external partners on development, validation, verification, and transfers
• Execute complex quality control tests using HPLC, TLC, GC, HPGe per regulations
• Support internal technology transfer of radiopharmaceuticals across BAMF Health network

Skills

Analytical equipment

GMP experience

CDMO familiarity

Quality systems

Education

Bachelor's degree in Applied Science

Tools

HPLC

GC

TLC

HPGe

Job description

BAMF Health in Grand Rapids, MI is seeking a QC Validation Specialist to join our radiopharmacy and analytics teams. You will develop study protocols, perform method validation, and lead equipment qualification activities in a GMP environment.

The role partners with operations, quality, regulatory, engineering, and chemistry to transfer technology, control documentation, and ensure compliance with QMS and GMP standards.