Hybrid Senior Quality Specialist, Systems and Continuous Improvement bei BAMF Health

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 Specialist, Systems and Continuous Improvement position at BAMF Health is an advanced role requiring a strong background in pharmaceutical quality assurance and compliance. The role is focused on maintaining the control and improvement of quality systems, ensuring adherence to regulatory standards, implementation of systems and managing quality system processes. It also involves tracking audits and inspections, ensuring commitments are met, and leading continuous improvement initiatives.

• Process improvement and ownership of quality management systems including but not limited to non-conformance, CAPA, change control, document control and training

• Implementation and maintenance of an electronic QMS

• Directs quality initiatives that accomplish continuous improvement and enhance process efficiencies, while providing a compliant process

• Monitor and track external audit/inspection commitments to ensure timely closure.

• Continuous improvement of quality systems and processes

• Skilled in planning and organizing, decision-making, and building relationships.

• Able to effectively multi-task.

Basic Qualifications:

• Bachelors of Science degree in life science, chemistry, or related field or equivalent required.

• Minimum of 5 years of experience with cGMP manufacturing, Quality, and compliance required.

• Excellent verbal and written communication skills required.

• Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management required.

• Advanced knowledge and experience with cGMP Quality, and compliance required.

Preferred Qualifications:

• MasterControl experience preferred

Schedule Details:

• Employment Status: Full time (1.0 FTE)

• Weekly Scheduled Hours: 40

• Hours of work: 8:00 a.m. and 5:00 p.m.

• Days worked: Monday - Friday (Hybrid position- 3 days required on site)

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

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.