The Accreditation Inspector shall be responsible for assessing activities, via record review and on-site observation, performed by tissue transplant and/or non-transplant establishments seeking accreditation with the American Association of Tissue Banks (AATB). (A complete list of tissue types and activities for which AATB accredits establishments can be found under the Accredited Bank Search on the AATB website). These establishments may be domestic or international. The inspector must possess and be able to demonstrate and effectively communicate in-depth knowledge and understanding of FDA regulations relative to human tissue for transplant and Standards published by AATB for human tissue transplant and non-transplant establishments. The contract inspector reports directly to the Director of Accreditation.
Specific Position Responsibilities
Responsible for communicating with assigned establishments to schedule and coordinate on-site assessments.
Performs inspection assessments at various locations in relation to AATB Standards and Accreditation Policies.
Completes and distributes post-inspection documents to the AATB Accreditation department within the specified timeframes.
Attends required meetings at the discretion of AATB.
This position requires a significant amount of travel (75%) with the remaining 25% of work performed remotely.
Required Education and Experience
Bachelor’s degree or equivalent experience in auditing and/or conducting inspections required, with ASQ CQA certification preferred.
Minimum 5 years of experience in a quality and/or audit-related position required with experience within the human tissue industry preferred. At least 2-3 years in an audit/inspection-related role is preferred.
Strong and effective oral and written communication skills.
Excellent attention to detail, strong organizational and interpersonal skills, and the ability to work well with others to bring complex projects to completion.
Proficient in MS Office (Word, Excel, PowerPoint) and ability to understand and navigate the Armature Fabric accreditation management software used in the association.
Thorough understanding of regulatory expectations of the FDA and other regulatory requirements as they may apply to tissue banking.
Knowledge of current AATB Standards for human tissue for transplant and non-transplant tissue.
Ability to maintain confidentiality and discretion.
The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific, and educational organization. AATB is the only national tissue banking organization in the United States, and its membership totals more than 120 accredited tissue banks and over 6,000 individual members. These banks recover tissue from more than 58,000 donors and distribute in excess of 3.3 million allografts for more than 2.5 million tissue transplants performed annually in the US. The overwhelming majority of the human tissue distributed for these transplants comes from AATB-accredited tissue banks.