Quality Assurance Specialist

BAMF Health • Grand Rapids, MI

15h • Onsite

About The Position

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 Quality Assurance Specialist is responsible for providing oversight and general support to the manufacturing/production of radiopharmaceuticals, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, and supports the Quality Management System. Oversight of the BAMF Health Quality Management System (QMS) and its associated programs. The BAMF Health PET Manufacturing Quality Management System is based on 21 CFR 212, USP <825> and other applicable standards and regulations. Assist with quality assurance initiatives and provide on the floor Quality oversight

Requirements

• Bachelor’s degree in Life/Physical Sciences or a related field or equivalent required
• 1 year of related work experience required
• Provide working knowledge of GMP and regulatory requirements as it relates to performing Quality Assurance review and approval of cGMP documentation
• Proficient in MS Office and eQMS applications

Responsibilities

• Review executed batch records and determine disposition of product
• Author and/or review SOPs, Change Controls, Deviations, OOS investigations, and CAPAs when necessary
• Conduct periodic audits to monitor compliance with established procedures and practices
• Ensure cGMP documents are properly organized, controlled, and securely archived
• Other responsibilities as required

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 11-50 employees