Description
SUMMARYResponsible for the maintenance of quality systems and facilitate continuous quality improvements. This position is responsible for the maintenance and monitoring of a variety of cGMP documentation including complaint files, complaint processing system, investigations and closure, CAPA's,
Essential Duties & Responsibilities
- Provide guidance to the team regarding the complaints to ensure appropriate action and closure.
- Conduct product and complaint investigations with follow-up as required for associated CAPAs.
- Analyze and report department metrics using Oracle and Microsoft-based applications.
- Assist with the maintenance of quality systems and facilitate continuous quality improvements.
- Conduct reviews and provide monthly reports for department metrics
- Write/revise procedures.
- Provides technical support to the team
- Support technical needs of the department.
- Assume and perform other duties as assigned.
- Train employees in SOP's and ensure training effectiveness in application of job skills
Supervisory Responsibilities
Supervise Complaint Specialist(s) and Returned Goods Technician(s).
EDUCATION/EXPERIENCES
Minimum Bachelor's degree (B.A.) from four-year College or university; Minimum two years related experience in Quality Assurance and/or training; or equivalent combination of education and experience. Experience supervising others is preferred. Minimum 1 year Nursing or Medical Background is highly desired.
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