Quality Specialist - TEMP - Noven Pharmaceuticals

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.

• 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.

Competencies:

Education / Experience:

Candidate must have a Science degree, a background in the Pharmaceutical Industry and 3-5 years’

experience in the processing customer complaints.  Must be computer literate and have good written and

verbal communication skills; data entry experience and familiarity with TrackWise software or

comparable system is a plus.  Must be detail-oriented to assure accuracy of completed tasks, and have

the ability to work independently or in a team setting. Must be able to manage multiple tasks at a time

and shift focus from one priority to another seamlessly.

Judgment / Decision Making:

Strong sense of ownership and accountability.

Work Environment:

Office environment.

Physical Demands:         

Light lifting of file boxes.