Senior Quality Specialist, Systems and Continuous Improvement

Senior Quality Specialist, Systems and Continuous Improvement – Grand Rapids, MI

• Process improvement and ownership of quality management systems, including non-conformance, CAPA, change control, document control and training.
• Implementation and maintenance of an electronic QMS.
• Direct 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.

• Bachelor of Science degree in life science, chemistry, or a related field (or equivalent) required.
• Minimum of 5 years of experience with cGMP manufacturing, quality, and compliance.
• Excellent verbal and written communication skills.
• Thorough knowledge and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Advanced knowledge and experience with cGMP quality and compliance.

• Experience with Master Control.

• Full time (1.0 FTE)
• 40 hours per week, 8:00 a.m.–5:00 p.m., Monday–Friday (Hybrid position – 3 days required on site)

• Employer-paid High Deductible Health Plan with employer HSA contribution
• Flexible vacation time
• 401(k) retirement plan with generous employer match
• Dental, vision, disability, life, supplemental coverages, legal and identity protection

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 to perform the essential functions of a job as long as it does not create undue hardship.