Senior Quality Assurance Specialist

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.

The Senior Quality Assurance Specialist works closely with members of the BAMF Health Radiopharmacy to set the strategy and direction for CMC efforts in support of technology transfer from clients which includes optimization of Manufacturing and Quality Control methodologies, quality and regulatory compliance, and relationships with collaborators and critical third-party vendors.

Duties and Responsibilities, including but not limited to:

• Review and approval of technical production and analytical documents including but not limited to:

  • Validation Master Plans

  • Process Performance Qualification Protocols

  • Analytical Test Method Validations / Verifications

  • Production Batch Records

  • Production Manufacturing Instructions

• Understand and Apply GMP practices and maintain the quality systems while on-boarding new projects

  • Assist with Deviations, CAPAs, and Change Controls associated with new projects

• Provide QA support to the project team including attend client interacting meetings

• Review executed batch records and determine disposition of product as needed

Basic Qualifications:

• Bachelor’s degree or equivalent in Life/Physical Sciences or a related field required

• 4 years of related work experience required

• Familiarity with a GMP manufacturing environment and working with FDA and FDA cGMP regulations is required.

Preferred Qualifications:

• Experience with aseptic filling preferred.

• PET experience preferred.

Schedule Details:

• Employment Status: Full time (1.0FTE)

• Weekly Scheduled Hours: 40

• Hours of work: 8:00 am - 5:00 pm

• Days worked: 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.