Complaint Analyst II at Mallinckrodt Pharmaceuticals in Hampton, New Jersey

Job Description:

Job Title

Complaint Analyst II

Requisition

JR000011558 Complaint Analyst II (Open)

Location

US Specialty Brand Headquarters - USA501

Additional Locations

Hampton, NJ

Job Description

Summary

This position reports to the Sr. Manager, Product Monitoring within the Quality Organization. This position is responsible for opening Commercial Complaints, identifying trends, processing metrics, ensuring timely investigations, and closing complaints through the system in a timely manner.

Essential Functions

* Capture, review, and analyze product complaints

* Comply with relevant global product quality related guidelines, standards, and regulations regarding the receipt, review, investigation, and reporting of product experiences

* Identify and understand the differences between product quality complaints, adverse events / incidents, medical information request, customer feedback, and regulatory agency requests

* Collaborate with Field Service, Quality, Engineering and/or Operations personnel to process complaints in a timely fashion

* Initiate and coordinate investigations for complaints

* Write and submit device Vigilance Reports for US, CA, AU and/or Europe

* Collaborate with colleagues, domestic and international

* Conduct trend analyses for Product Monitoring

* Prepare and deliver accurate reports of product performance

* Identify potential product performance issues and alert the appropriate Management personnel, as required

* Escalate quality and/or safety concerns reported / experienced by the customer

* Work in conjunction and effectively communicate with various departments, including R&D, Engineering, Marketing, Medical Affairs, Technical Service, and Customer Care

* Provide support during audits and regulatory inspections, as required

* Perform other duties as assigned

Minimum Requirements

Education / Experience / Skills:

• Bachelor degree required; in a Science, Math or Engineering related field is preferred


• 2 - 5 years of experience in medical device, biologics, and/or pharmaceutical manufacturing is required


• Knowledge of regulations and standards (21CFR 820, 21CFR 803, 21CFR 210/211, MDD, ISO 13485, CMDCAS, etc.); as they apply to complaint management is desired


• Knowledge of Vigilance Reporting concepts is desired


• Demonstrated organizational, problem-solving, analytical and time management skills is desired

Competencies:

• Proficient with Microsoft Office (Excel, Word, and PowerPoint)


• Experience with Microsoft Minitab is beneficial


• Knowledge of complaint databases (e.g., MasterControl) and ERP systems (e.g., SAP)


• Ability to interface with both technical and non-technical personnel at all organizational levels


• Ability to read and understand technical documentation including Service Orders and investigations
  Ability to understand device, drug and/or biologic operational activities is desired


• Excellent interpersonal, written English, and oral communication skills

Organizational Relationship/Scope:

The position reports to the Sr. Manager, Product Monitoring and interacts with R&D, Engineering, Marketing, Medical Affairs, Field Reps, Product Support, Technical Services, and Customer Care.

Working Conditions:

This position works in an office type environment. Long periods of sitting are required. Use of computer and phone are required on a daily basis.

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