Job Description
Job DescriptionDescription:
Job purpose
The internal auditor is responsible for executing and maintaining a comprehensive and effective internal auditing program compliant to Standard Operating Procedures in addition to FDA, AATB, and State regulations and standards. The internal auditor must have strong verbal and written communication skills.
Duties and responsibilities
- Assist in development of internal audit plans and schedules.
- Perform recurrent inspection rounds of the different tissue bank departments.
- Perform periodic internal audits of all quality systems for compliance with federal, state, and accrediting bodies regulations and standards.
- Draft inspection results/ audit reports to communicate the outcomes of audit to the corresponding management staff.
- Track and manage post-audit and inspection activities, support and follow-up on any necessary corrective and preventive actions.
- Support the maintenance of federal, state, and accrediting bodies licenses and registrations, as needed.
- Assist is third party qualification audits
- Perform other duties as assigned by the Regulatory Affairs Supervisor and/or Regulatory Affairs Management.
Requirements:
Qualifications
Education Required: Bachelor’s Degree preferred.
Experience: 1-2 years of experience in an auditing role preferred. Possess working knowledge of technical concepts required for cGTP, and cGMP auditing in the tissue, medical device, biologics, or pharmaceutical industries.
Licenses/Certifications: CTBS or ASQ certification preferred.
Working conditions
Position is maintained in a quiet office environment; however, most of the time will be auditing or inspecting processes on-site while interacting and engaging with employees to support business operations.
Physical requirements
While performing the duties of this job, the employee is regularly required to sit; stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 25 pounds.
Direct reports
No direct reports.