Job Description

Job Summary:


Under the direct supervision of the Compliance Analyst, the Compliance Technician I will perform activities .





Scope: Under the direct supervision of the Compliance Analyst, the Compliance Technician I will perform activities related to:

Experience:

Minimum of two years of experience in similar functions.

Education:

Associate degree or equivalent experience

Essential Functions & Accountabilities:

Assign tracking number to SOPs, protocols, DCR, and deviations. Revise SOPs format. Assist initiators on SOPs requirements/cross reference/deviation/DCR/DCO/ECO. Evaluate and approve DCR / DCO & ECO. Distribute/retrieve official documentation as applicable. Maintain and update electronic and manual documentation files. Maintain good recordkeeping of SOPs and Quality Records. Receive, file and retrieve Quality Records. Maintains workflow. Determine the risks related to a Complaint/Quality Feedback/International Return and document the need for investigation. Revise procedures when required. Contact SSF/UK for Complaint/Quality Feedback/International Return data as required. Retain product samples upon complaint closure. Maintain and update database for Quality Technical, Complaints, Quality Feedback and International Returns. Retain medical product samples. Coordinate destruction of samples with technicians. Assist Compliance Technicians on technical evaluation, results determination, and/or complaints disposition and provide training as required. Assist Quality Improvers as requested. Train new hires on Good Documentation Practices procedure Manage trend monthly reports for Complaints and Quality feedback

Quality System Responsibilities

Complies with the Quality System Regulation (QSR). Executes job responsibilities as established in the Standard Operating Procedures (SOP). Follows the documentation procedures. Completes training for the qualification and certification, as required, to execute the job.

Safety & Occupational Health Responsibilities

Complies with Safety and Occupational Health Policy and procedures. Complies with Hazardous Communication program. Notifies immediately all accidents or incidents occurred in work area. Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable.

"We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace."