Product Complaint Associate

1 month ago

North Wales, United States Collabera Full time
Job DescriptionJob Description

About the Role:

  • Be able to open the sample to do a visual inspection and triage and classify them accordingly.

  • Be able to process and inspect various Organon Products like inhalers, syringes, vials, etc.

  • Have good communication skills to hold productive conversations with multiple cross-functional teams.

  • Have leadership skills and be able to think critically and analytically.

  • Have experience with MS Office/Teams.

  • Good to have experience with software like QCC4 and SAP.

 

Responsibilities:

• Responsible for executing relevant procedures to ensure Product Quality Complaint (PQC) and Adverse Event Quality Investigation (AE-QIR) intake management processes comply with regulatory expectations.

• Responsible for receipt, processing, and follow-up of Product Quality Complaints or Adverse Event Quality Investigation Requests.

• Acts as an effective liaison between Organon support functions worldwide for complaint-handling activities to maintain regulatory compliance.

• Provides expertise in complaint-handling processes and systems to resolve issues and drive continuous improvement.

• Manages the intake of complaint samples for the US market. Identifies appropriate investigating sites, documents sample information, prepares the sample for shipment to the investigating site when designated by LCIU, performs functional testing, and documents all findings in the complaint records.

Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.

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