Noven Pharmaceuticals

Quality Specialist

Noven Pharmaceuticals  •  Miami, FL (Onsite)  •  3 hours ago
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Job Description

Overview

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.

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.

Qualifications

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.

Noven Pharmaceuticals

About Noven Pharmaceuticals

Noven Pharmaceuticals, Inc. is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. We are committed to developing and offering pharmaceutical products that meaningfully benefit patients, with a commitment to advancing patient care through transdermal drug delivery.

Over 300 Noven colleagues are working to advance our business and benefit patients at locations in Miami, FL, Jersey City, NJ. We are a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., the world’s largest manufacturer of transdermal patches, and we serve as Hisamitsu's growth platform for U.S. prescription pharmaceuticals.

Noven maintains state-of-the art, FDA-approved transdermal manufacturing facilities in Miami with capacity to produce several hundred million patches per year. These facilities are also approved by the U.S. DEA (Drug Enforcement Agency) for the production of controlled substances.

Industry
Chemicals & Materials
Company Size
501-1,000 employees
Headquarters
Miami, Florida
Year Founded
1987
Website
noven.com
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