Under minimal supervision, this position is responsible for performing activities related to process and equipment validation, corrective and preventative action reporting, internal and external audits, and supervising daily, ongoing activities related to allograft labeling, documentation review, and QC inspections of processed HCT/Ps. This position requires attention to detail and must be performed in accordance with current Regenative Labs Standard Operating Procedures (SOPs), as well as all Food and Drug Administration (FDA), American Association of Tissue Banks (AATB), International Organization of Standardization (ISO) 13485, and other regulatory agencies as necessary.
This position reports to the Director of Quality Management and is responsible for communicating effectively with other individuals within the organization. This position may provide support to other departments as necessary.
Bachelor's degree in a technical field, with at least 2-3 years of Quality Assurance and/or Quality Control experience in a tissue bank, biologic, medical device, pharmaceutical, or FDA regulated facility, preferred.
Experience with standard operating procedure creation and revision (document control).
Extensive knowledge of FDA 21 CFR Part 1271, ISO 13485, cGTP, and AATB Standards and Requirements.
Experience with aseptic technique and processing of donor tissue preferred.
Regenative Labs' mission is to facilitate predictible patient outcomes by providing the highest quality human tissue allografts available. With the goal of addressing the root cause, rather than masking the pain, Regenative Labs birth tissue allografts provide a non-addictive, non-invasive option for patients.
