Quality Specialist

Noven Pharmaceuticals•Miami, FL

3d•Onsite

About The Position

Perform all activities related to investigation of customer complaints, process return samples for credit and reconcile call center complaints. Ensure on-time closure of complaint records and tasks associated with data requests from other departments. Identify critical complaints and prioritize these investigations to meet reporting requirements. Monitor complaint activity for trends and conduct trend investigations as appropriate. Generate and report metrics for monthly Council meetings, quarterly status meetings and annual product reviews. Participate and support in all team activities and projects as assigned.

Requirements

Science degree
Background in the Pharmaceutical Industry
3-5 years’ experience in the processing customer complaints
Computer literate
Good written and verbal communication skills
Data entry experience
Detail-oriented to assure accuracy of completed tasks
Ability to work independently or in a team setting
Able to manage multiple tasks at a time and shift focus from one priority to another seamlessly

Nice To Haves

Familiarity with TrackWise software or comparable system is a plus.

Responsibilities

Initiate, investigate, summarize and close complaint records for Noven products using the TrackWise System.
Interact with individuals internally and externally to obtain information required for completion of complaint investigations.
Drive on-time closure of all complaint records and related tasks.
Identify critical complaints and complete investigations within required time period.
Generate and report complaint metrics in weekly progress reports and meetings.
Summarize complaint data for APR reports
Update and draft SOPs as deemed necessary.
Comply with all training requirements.
Comply with all Company policies and procedures, including safety rules and regulations including cGMPs,FDA regulations and other regulatory requirements.
Perform other duties and projects as assigned by the Director.