QA Donor Eligibility Associate

At MIMEDX, our purpose starts with helping humans heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care & surgical products, we are committed to making a transformative impact on the lives of patients we serve globally. Will you join us on this journey? We are excited to add QA Donor Eligibility Associate to our Quality Assurance team! This role will be a hybrid position. The position will pay between $20.00-30.00 per hour based on previous relevant experience and educational credentials.

POSITION SUMMARY:

Will review all donor records to determine eligibility of donated tissue for processing to ensure compliance with all standard operating procedures (SOP's), guidelines, and regulations. Identify, research, and obtain needed information. Work with internal medical experts and management when necessary to receive guidance before making recommendations on eligibility of donor tissue for the manufacture of product. Verify proper labeling of tissue throughout the entire process, from recovery to release for processing. Collect, track, and report on data related to the tissue recovery process.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform thorough review of all donor medical records and social histories, with emphasis on compliance to approved quality guidelines (administrative, medical, technical perspective)
• Identify and obtain necessary/missing information from all tissue recovery resources (internal and external)
• Work with external lab resources to monitor accuracy and status of tests/services requested by tissue recovery resources (internal and external); assist in resolving issues regarding requested services (e.g. type of test(s) needed, missing information on lab order form, etc.)
• Perform thorough review of tissue labels, with emphasis on compliance to approved quality guidelines; confirm proper labeling and identification has been maintained throughout the recovery process on both quarantined and released, raw tissue containers
• Perform physical release of tissue for processing or discard, as appropriate (e.g. pull from quarantine area, apply proper labeling to container, deliver tissue to processing or bio-waste area, etc.)
• Make recommendations on eligibility of recovered tissue for processing, working with in-house medical expert as needed for clarification and guidance

EDUCATION/EXPERIENCE:

• HS Diploma or GED
• Specialized skill training; certification may be required
• 3+ years of experience in area of responsibility
• Prefer knowledge of AATB, FDA, and other state/federal regulations

SKILLS/COMPETENCIES:

• Excellent oral, written, and interpersonal communication skills
• Proficient in Microsoft Office (Excel, Word, etc.)
• Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
• Must show aptitude to develop appropriate skills needed for the job