We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care.

The QA Specialist performs quality activities in support of Cell Bank production, and release of Tissues and Cell Banks. The position has a great deal of interaction with many internal departments, including Media Production, Apligraf Production, Cell Culture, Facilities, Validation, Calibration, Materials, Quality Control, and Logistics. The position may also have interactions with external entities including contractors, suppliers, and customers. The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting audits, training programs, data analysis, and documentation reviews. This position reports to the Quality Assurance Manager. Primary responsibilities include:

• Review Cell Bank production batch records, data forms, and other associated documentation. Help identify discrepancies and work to obtain resolution of the discrepancies with the responsible individual(s).
• Review Cell Bank testing and ensuring that all specifications are met.
• Disposition of Tissues and Cell Banks as needed.
• Enter product lot information and data into the MBR database(s).