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

Join BAMF Health, where you're not just part of a team; you're at the forefront of a revolution in Theranostics, changing lives for the better. As a member of our global team, you'll contribute to pioneering technology and deliver top-tier patient care. Located in the heart of downtown Grand Rapids, our cutting-edge global headquarters resides within the state-of-the-art Doug Meijer Medical Innovation Building. Step into our modern and spacious facilities, where innovation thrives and collaboration knows no bounds. Join us in our mission to make Theranostics accessible and affordable for all, and be part of something truly remarkable at BAMF Health.

QC Validation Specialist works side by side with our operations, quality and regulatory, engineering, and chemistry teams to advance the mission of the BAMF Health Radiopharmacy.

Duties and Responsibilities, including but not limited to:

• Protocol and Documentation Generation: Develop study protocols and controlled documentation to facilitate technology transfer and qualification of contracted radiopharmaceutical products.
• Testing and Validation Execution: Perform testing activities for process qualification and method validation according to protocols and SOPs, and prepare comprehensive study reports as needed.
• Equipment and System Qualification: Oversee equipment qualification, computer system validation, and cleaning verification protocols in collaboration with validation personnel.
• Deviation and Exception Management: Lead investigations and thoroughly document deviations and exceptions occurring during the technology transfer process.
• Training and Production Support: Train BAMF Radiopharmacy personnel on new testing procedures and provide ongoing support for routine production following technology transfer.
• Instrumentation Operation and Maintenance: Facilitate daily operation, maintenance, and cleaning of analytical testing equipment, ensuring all related laboratory equipment is in optimal condition during technology transfer.
• Collaboration for Development and Validation: Work closely with internal teams and external partners on development, validation, verification, and method transfers for radiopharmaceutical manufacturing and quality control.
• Complex Quality Control Processes: Execute complex quality control tests using analytical equipment such as HPLC, TLC, GC, and HPGe, in compliance with state and federal regulations.
• Internal Technology Transfer Support: Support the internal technology transfer of radiopharmaceuticals across the BAMF Health network to ensure seamless integration and alignment.
• Risk Management and GMP Compliance: Identify barriers to program objectives, communicate risks and mitigations to leadership, and ensure all documentation aligns with BAMF’s Quality Management System (QMS) and GMP manufacturing principles.

Basic Qualifications:

• Bachelor’s degree or equivalent in Applied Science or equivalent required
• 2 years hands- on experience with analytical equipment working in a GMP environment in the pharmaceutical or biotechnology industry required
• Familiarity with CDMO and CMO work required
• Foundational expertise in the setup, operation, and maintenance of conventional analytical instrumentation (HPLC/GC/TLC/etc.) and modern chromatography data systems required
• Experience in method transfer of HPLC, TLC, or GC QC required
• Demonstrated experience in the operation, use and maintenance of pharmaceutical production equipment and cleanroom facilities required

Preferred Qualifications:

• BS Degree in Applied Science preferred
• Experience in the operation, use, and maintenance of pharmaceutical production equipment and cleanroom facilities is preferred
• Experience in the setup, operation, and maintenance of conventional analytical instrumentation (HPLC/GC/TLC/etc.) and chromatography reporting is preferred
• Familiarity with pharmaceutical compendia (USP, NF, ICH, etc) is preferred

Schedule Details:

• Employment Status: Full time (1.0FTE)
• Weekly Scheduled Hours: 40
• Hours of Work: 5:00am-1:00pm
• Days: Monday to Friday
• Location: Grand Rapids, MI

At BAMF Health, our top priority is patient care. To ensure we are able to drive a Bold Advance Medical Future, we offer a well-rounded benefit package to care for our team members and their families. Highlights include:

• Employer paid High Deductible Health Plan with employer HSA contribution
• Flexible Vacation Time
• 401(k) Retirement Plan with generous employer match
• Several benefit options including, but not limited to; dental, vision, disability, life, supplemental coverages, legal and identity protection
• Free Grand Rapids downtown parking

Disclaimer BAMF Health provides equal opportunities to all employees for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. BAMF Health will reasonably accommodate qualified individuals with a disability so that they can perform the essential functions of a job unless doing so causes a direct threat to these individuals or others in the workplace and the threat cannot be eliminated by reasonable accommodation or if the accommodation creates an undue hardship to BAMF Health. BAMF Health is an Equal Opportunity Employer and will not accept or tolerate discrimination or harassment against any applicant, employee, intern, or volunteer based upon the following characteristics: race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability or handicap, sexual orientation, gender identity/expression, transgender status, genetic information, pregnancy or pregnancy-related status, marital status, veteran status, military service, any application for any military service, or any other category or class protected by applicable federal, state, or local laws. BAMF Health is creating a Bold Advanced Medical Future by developing a network of advanced cyclotron equipped Radiopharmacies and Theranostics centers. Powered by our proprietary AI platform, our clinics deliver personalized treatment to patients with cancer and neurodegenerative diseases. At BAMF Health, we are committed to creating a diverse, inclusive, and equal opportunity workplace. BAMF Health’s Clinicians, Researchers, Radiopharmacy, Engineering, Technology, and Operations experts have designed, planned, and built the world’s most advanced platform for Theranostics at our global headquarters in Grand Rapids, Michigan. The world-leading Theranostics Center includes the world’s most advanced dual-cyclotron equipped Radiopharmacy, Molecular Imaging Clinic with Total Body PET/CT and PET/MR scanning capabilities, and molecular therapy clinic with advanced SPECT/CT application. Our platform brings together commercial radiopharmaceutical manufacturing, intelligence-based clinical application, advanced clinical trials, and novel AI integration all under one roof. BAMF’s world-class healthcare facility is leading the health care industry towards a Bold Advanced Medical Future, where patients are empowered to regain their quality of life.