For more than 20 years, AlloSource’s allografts have been the biologic solutions our surgeon customers use to deliver better care to their patients. As one of the largest and most respected nonprofit tissue banks in the United States, AlloSource develops, processes and distributes over 200 types of life-saving and life-enhancing allografts for use in a variety of medical procedures. Our commitment to honoring the gift of tissue donation motivates us to develop innovative allografts and lead the way in cellular and tissue therapies.
Must comply and ensure adherence with FDA, CGTP, OSHA, AlloSource SOPs, work instructions & procedures, proper practices and techniques, AATB standards, and applicable company policies, training requirements, safety practices and regulatory requirements that are applicable to the job responsibilities.
The Acceptability Technician has the responsibility and authority to approve or reject tissue, as well as discontinue Processing and/or release of tissue. The Acceptability Technician is responsible for handling technical aspects of AlloSource’s Quality Control Program within the Controlled Work Area, Donor Receiving, Vessel Manufacturing, and Final Labeling. This includes the review of processing records, completion of quality documents, and visual inspections of in process and final labeled tissue, in accordance with all applicable regulatory standards. Frequent communication with multiple departments is an integral part of the job.
Essential Duties and Responsibilities:
- Participate in Donor Receiving activities, ensuring all required information is present and donor requirements are met.
- Evaluate session/batch records for approval and ensure that any corrections are identified and completed prior to acceptance.
- Review session/batch outputs to ensure all products meet the applicable specification and regulatory requirements.
- Ensure physical outputs match electronic outputs and ensure the appropriate QC samples were taken.
- Visually inspect all in process and final labeled product per the applicable specification. Ensure all visually rejected tissue is dispositioned appropriately through the applicable Quality System.
- Ensure timely and accurate sample processing, which includes sample handling, preparation, documentation, data entry, assignment of test codes, and distribution of all Quality Control Tests intended for various testing laboratories.
- Ensure the proper storage and handling of all Quality Control Tests until sample processing is complete.
- Prepare samples to be shipped to the testing laboratories in accordance with applicable procedures.
- Provide technical support and act as a technical resource for all sample management and sample submission related activities.
- Contact testing laboratories, when necessary, to obtain and clarify missing or unclear information to ensure that identification of test codes and sample contents are accurate.
- Assist Quality Management in collection of data, analysis of data, and report development.
- Responsible for quality review of all final labeling release activities.
- Review final labeled product and ensure that any corrections are identified and completed prior to final release.
- Coordinates decisions for corrections and elevates to Supervisor as necessary.
- Involved in making quality decisions about products based on requirements outlined in SOPs, WIs, and Specs.
- Participate in projects impacting production, inventory or evaluation and maintain consistent cross-functional communication with all departments, shifts and management.
- 2 years Quality Assurance or Quality Control experience working in a regulated industry
- Proficiency in Microsoft Applications, specifically Excel, Word and Outlook
- High School Diploma or equivalent
- 4 years any combination of relevant Quality Assurance or Quality Control experience working in a regulated industry
- Bachelor’s degree in a science related field
For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.
AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.