Complaint Handling Unit Specialist - Spring House, United States - Themesoft Inc.

    Themesoft Inc.
    Themesoft Inc. Spring House, United States

    3 weeks ago

    Default job background
    Healthcare
    Description

    Job Title: Complaint Handling Unit Specialist

    Location: Spring House, Pennsylvania.

    Duration: Long Term

    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.

    Comments/Special Instructions

    MUST HAVE

    1) Background in Science.

    2) Good Leadership and communication skills.

    3) Good analytical skills.

    During the contract's start, the person WILL BE ON SITE EVERY DAY, this could be at least a month but is subject to change and the contractor should be comfortable coming to the office beyond that as well if need be. Eventually, it will move to 3 days a week on site but this should not be expected to happen immediately. There should be flexibility in coming to the office as and when required.