- Support the quality objectives of the Cellular Therapy Laboratory (CTL) and Apheresis Procedure Unit (APU).
- Assist APU and CTL staff in ensuring that products and services meet and exceed customer expectations.
- Participate in Quality and Regulatory audits.
- Monitor Quality Control and Quality Assurance activities for the CTL and APU.
- Ensure vendor qualification meets CTL/ APU requirements.
- Participation in BMT and cellular therapy Quality meetings.
- Manage product and material recalls.
- Keep up on standards, regulations/ laws and issues with respect to product quality and apheresis procedures.
- Use multiple computer and file storage systems to perform inquiries and post documents and records on shared drives.
- Follow safety requirements for personal protection and patient safety.
- Participate in continuing education programs.
- Maintain confidentiality of information and is sensitive to the privacy of all patients, donors and staff members.
- Bachelor's degree in Clinical Laboratory Science or the equivalent combination of education and experience.
- 3 to 5 years’ experience in Quality Management .
- The preferred candidate should have the ability to independently organize and prioritize work, they should have excellent communication skills.
- The candidate should also have a strong knowledge of Good Tissue Practices and Good Manufacturing Practices (GTP/ GMP) as well as knowledge of AABB, FACT and CAP accreditation requirements.
Knowledge of MS-Office including Word, PowerPoint and Excel is highly desirable.
This full time, 40 hour position is on the day shift and may require rotating weekends, holidays and on-call schedule.
This position will include working with infectious diseases and/or hazardous materials, exposure to noise from laboratory equipment and pneumatic tube system as well as exposure to liquid nitrogen. It will also include walking, standing, lifting and bending frequently.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.