Cellular Therapy Quality Assurance Specialist

Full time M-F (8AM-4:30PM)

1.    General Summary

Under general supervision of the Associate Director of Transplant and Cellular Therapy with medical input from the Medical Director of the Cellular Therapy Lab and the Facility Director oversees and coordinates the quality assurance activities requirements licensure requirements and accreditation activities as well as develops quality programs of the Cellular Therapy Laboratory and Fannie Angelos  Cellular Laboratory.
 
II.          Principal Responsibilities and Tasks

The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.
 
1.    Supervise/develop the Quality Assurance of the Cellular Therapy and Fannie Angelos Cellular Laboratories to comply with all applicable regulatory and accreditation requirements including FDA AABB CLIA CAP TJC FACT and OSHA standards and requirements.

• 1.    Manage quality assurance program.
• 2.    Assure compliance with regulations.

2.    Write review edit and validate standard operating procedures with laboratory leadership.
3.    Represent the Laboratories for inspections by FDA AABB CAP TJC and FACT.
4.    Develop and implement the performance and documentation of internal auditing.
5.    Write edit perform and evaluate validation plans.  Quality assurance specialist should manage program document trends assure follow-up etc.
6.    Develop implement document training and education program equipment program and safety program in conjunction with the lab leadership.
7.    Reviews all occurrence reports with the lab and clinical leadership interacts with related departments such as Risk Management Quality Improvement Committee Infection Control Facilities Management Biomedical Engineering Environmental Services UMMS and UMAB Environmental Health and Safety Departments as required.
8.    Develop self-inspection teams throughout the Laboratories to ensure and improve current practices to keep up with and implement future practices.
9.    Direct plan or participate in laboratory staff orientation training and competency evaluations.
 

Qualifications :

Education and Experience
1.    Baccalaureate degree from an accredited college in a relevant discipline required.
2.    Four years of progressively responsible experience in a lab required.
3.    Two years of Quality Assurance experience and preferred working knowledge of AABB FDA FACT TJC CLIA and CAP Transfusion Services and Blood Donor Center are essential.
4.    Certification as a medical technologist or equivalent preferred or an equivalent combination of education and experience.
 
Knowledge Skills and Abilities
1.    Demonstrated verbal and written communication organizational interpersonal skills.
2.    Demonstrates basic computer literacy and the ability to coordinate and complete multiple projects in an effective timely manner.
3.    Must be self-motivated and able to work independently.
 

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Compensation

• Pay Range: $49.65-$60.68
• Other Compensation (if applicable):

Review the 2024-2025 UMMS Benefits Guide