Valeant Pharmaceuticals

Product Complaint Specialist

Job Location US-SC-Greenville
Job ID
9956
Pos. Category
R&D
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The Quality Analyst supports the MQA organization through the review and completion of customer complaints for products manufactured in the Greenville Solutions Facility. 

 

Receive, review, investigate, and disposition complaint records received from product surveillance groups and customer service. Complete trending of complaints for monthly review in addition to annual assessments. Preparation & presentation of trend reports for management.

Responsibilities

  • Receive, review and disposition complaint records received from Product Surveillance groups.
  • Coordinate sampling, testing, documentation and Greenville complaint response as required.
  • Elevate issues and initiate corrective action documentation via Catsweb, as required.
  • Champion root cause investigation and reporting activity to ensure timely responses.
  • Complete complaint report documentation in a timely manner and identify other local contributors as required.
  • Ensure product samples are identified, collected, and forwarded to Greenville Laboratory and/or external test facilities, as required based on the problem type.
  • Investigate correlation between Customer Complaint incidence versus other operations exception documentation (NC/CAPA) to assess scope, incidence rate and severity of Customer Complaint issues.
  • Identify risk factors which may suggest negative product performance indicators or trends, and escalate issues for technical review.
  • Development of data analysis for use in routine complaint reviews, product quality reviews, management reviews, and other audits and reviews.
  • Complete trend reports as required for monitoring.
  • Key Relationships: Chemistry, Microbiology, Operations, Supplier Quality, MQA (Line Inspectors, Release Coordinators, & Quality Engineers), GPS and Customer Service.

 

Qualifications

  • Chemistry, Microbiology, Operations, Supplier Quality, MQA (Line Inspectors, Release Coordinators, & Quality Engineers), GPS and Customer Service.
  • Education:  Four-year college degree (BA/BS) in fields such as life, physical sciences, or engineering.
  • Experience: 2-5 years of prior office and/or computer (Microsoft Office) experience required. 2-5 years of QA experience. Need to demonstrate a strong understanding of GMPs and Quality system regulations and current industry practice.
  • Experience: Regulatory, Quality experiences in the medical device and/or pharmaceutical industry a plus. Experience in Customer Service related activities preferred.
  • Skills: Well organized with the ability to multi-task and shift priorities as needed to meet customer demands.  Good communication, interpersonal and writing skills. Ability to organize and prioritize work effectively. Advanced computer skills, and experience with use of Microsoft Word, Excel, Microsoft Outlook.   Demonstrated proficiency in Microsoft Office to include use of Excel spreadsheets, Microsoft Word, PowerPoint. Should be able to trend and graph data for presentation to management.

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

 

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