The Quality Assurance Auditor is responsible for executing and maintaining a comprehensive and effective internal and external auditing program compliant with FDA, AATB, and State regulations and standards. This person is also responsible for the onboarding and qualification of recovery partners, processors, suppliers and distributors. The QA Auditor will be directly involved with inspections by regulatory and accrediting bodies. This role will be expected to support the maintenance of licenses, registrations, and accreditations for the organization.
Assist in development of audit plans and schedules.
Perform periodic internal audits of all tissue bank quality systems for compliance with federal, state, and accrediting bodies.
Develop audit reports to communicate the outcomes of audits to the corresponding management staff.
Track and manage post-audit activities and support and follow-up on any necessary corrective and preventative actions.
Assist with the partner, supplier, processor, and distributor qualification program to ensure that these entities are in compliance with federal, state and accrediting bodies' regulations and standards.
Actively participate in hosting facility inspection by regulatory and accrediting bodies as needed.
Assist with regulator compliance requests received from outside partner agencies.
Support the maintenance of federal, state and accrediting bodies' licenses and registrations.
Perform other duties as assigned by the Regulatory Affairs Supervisor and/or Regulatory Affairs Management.
Bachelor's Degree required.
2 years' experience in the Tissue Banking, Device, Biologics, or Pharmaceutical industry preferred.
Good verbal, written, organizational and communication skills.
Must possess high attention to detail and above average analytical skills. Must be able to exert sound independent judgement.
Excellent interpersonal skills involving ability to work independently and effectively with a cross-functional team.
Have working knowledge of the technical concepts required for cGTP and cGMP auditing in the tissue, device, or biologics industries.
Working knowledge of Microsoft Outlook, Internet Explorer, Excel, Word, PowerPoint and MS Project software.
About Vivex Biomedical
About Vivex Biomedical, Inc.
Vivex Biomedical is a regenerative biologics company, dedicated to creating new standards in patient care. Vivex Biomedical strives to create treatment options and solutions that will improve clinical, surgical, and therapeutic patient care through innovation. Under the guidance of experienced and successful business professionals, Vivex Biomedical tasks the brightest minds from the medical and material science industries to explore new and different ways to help others. Vivex Biomedical focuses on core products and new technologies to meet the ever-growing biologic needs of surgeons and patients while continuing our 45 year history of serving and honoring both tissue donors and recipients. As a part of this mission, Vivex Biomedical works with services that are committed to providing care and compassion to donor families while inspiring communities to share life through their donation. Partnering with families in the prospect of regenerative options, Vivex Biomedical assures appropriate options are available to support regeneration and translation of their gifts. Vivex Biomedical and its affiliates have distributed more than two million tissue allografts to 18 countries worldwide to better serve the needs of patients.