Participate as the Lead Assessor in the evaluation of a facility's conformance to quality management system and operational standards. Serve as the team lead with volunteers.
Major Responsibilities:
Work closely with the Accreditation and Quality staff and volunteer assessors to ensure on-time completion of assessments.
Complete assessments according to schedule.
As part of the Accreditation and Quality team, develop and continuously fine-tune the accreditation process.
Act as a mentor for volunteer assessors. Participate in the delivery of pre-established training programs for assessors.
Keep current with regulations, practices, and issues pertinent to the blood banking, cellular therapy, and relationship testing communities.
Serve as a project manager, resource and accreditation program support for volunteer assessors.
Participate as an instructor, preceptor, and supervisor of assessors in training.
Serve as a CT Subject Matter Expert contact between assessors, facilities and the Accreditation and Quality team.
Attend CT Standards Committee meetings whenever possible. Shares relevant information with Accreditation Staff.
Attend FDA, HRSA, Pharma Conference, NMDP Council Meetings, ICCBBA ISBT 128, and other SME meetings whenever possible; serves as a representative from AABB and shares relevant information with Accreditation Staff
Perform surveillance of internet websites:
Monitor Accredited facility websites to ensure appropriate logo use.
Monitor inappropriate claims of AABB accreditation.
Communicate with facilities when inappropriate advertising or claims are made and cc the Director of CT Programs and Global Outreach on those communications.
Education and Experience:
Education - Bachelor's degree in medical technology or related discipline, MS and / or PhD preferred
Certifications - SBB, CQA (ASQ) and / or CABP preferred
Experience- Three or more years of recent auditing / assessment experience and three or more years' experience in cellular therapies and / or three or more years experience in blood center and transfusion service operations or three or more years of relationship testing required.
Minimum of two years of personnel management (managing assessors preferred).
Experience in Cellular Therapy activities.
Technical Competencies:
In-depth knowledge of auditing / assessment principles and ability to apply those principles to the assessment of organizations engaged in blood manufacturing, transfusion medicine activities, cellular therapy activities and relationship testing activities.
Excellent organizational and time management skills, with demonstrated ability to manage multiple projects and meet deadlines.
Strong written and oral communication skills.
Ability to direct, supervise and coach assessment team members. Must be able to share information and seek consultation effectively and have strong project management skills.
In-depth knowledge and understanding of:
Quality Management Systems including ISO 9000 and AABB Quality System Essentials
AABB Standards, FDA, OSHA, CLIA, and other regulations as they apply to the blood banking and cellular therapies fields.
Familiarity with Foundation Association Cell Therapy (FACT) requirements and tissue-related regulations (if applicable).
Scientific principles underlying blood banking policies and procedures.
Ability to present educational programs and train assessors.
Staff Requirements:
Working knowledge of Microsoft Office programs, including Excel, Word, PowerPoint, Outlook, and other programs and databases as needed.
Use of general office equipment.
Participates in projects and other functions as needed.
Documents necessary for international travel.
Perform other related duties incidental to the work described herein.
Physical Requirements:
This position requires sitting (60%), standing (15%), and walking (25%). Additional physical requirements are as follows:
Requires lifting materials of approximately 25-50 lbs.
Often requires computer responsibility which involves extensive use of keyboard, mouse and monitor.
Work Environment / Conditions:
Dayshift hours primarily
Travel 85-90% of time, sometimes on short notice as needed. Travel and other work related assignments on weekends are possible.
AABB is the international association of blood banks, including hospital and community blood centers, transfusion and transplantation services and individuals involved in activities related to transfusion and transplantation medicine.More than 2,000 institutions (community and hospital blood banks, hospital transfusion services and laboratories) and 11,000 individuals are members of the AABB, including physicians, scientists, administrators, medical technologists, blood donor recruiters and public relations personnel. Members are located in all 50 states and more than 80 foreign countries.