The Compliance Auditor manages both the internal and external audit programs, maintains a Supplier Quality Management program, and serves on the host team during inspections of the Marietta facility. Responsible for implementing inspection readiness programs and driving responses to audits. The Compliance Auditor defines and implements procedures to assure that vendors and outside services contracted to assist in the manufacture and packaging of commercial and/or clinical products comply with internal and US/international standards and guidelines. Audits may include internal/external GxP (excipient/API/component suppliers, contract laboratories, contract manufacturers and CRO’s) and due diligence audits.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. The employee is regularly required to sit, use the hands and fingers to type via the use of the PC (Personal Computer). There are no lifting requirements; however, travel is expected so the general transport of a laptop and personal luggage will take place. No Personal Protective equipment required, unless entering production areas.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.