Taiho Oncology

  • Sr. Analyst, Quality Assurance

    Job Locations US-NJ-Princeton
    Category
    Quality Assurance
    Type
    Regular Full-Time
  • Position Summary

    Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy. Due to the highly regulated and confidential nature of Quality Assurance, this position requires a positive and experienced professional with a focus on high quality detailed work, initiative, sound judgment, and work ownership. The incumbent is responsible for initial receipt and log-in of product complaints, assessment and maintenance of other QA documents, as assigned. The incumbent must have a demonstrated proficiency in Microsoft office, work in collaboration with others and provide independent thought to improve processes for projects and department operations with the ability to communicate effectively at all levels of the company. 

    Responsibilities

    • Receive and enter complaint information into the complaint database for evaluation by QA GMP.
    • Evaluate the initial complaint and determine the need for investigations
    • Identify product complaints that may be linked to an adverse event
    • Sends out requests for complaint follow-up based on the complaint evaluation
    • Maintain and complete PQC monthly notebooks
    • Track complaint progress to ensure complaints are closed on time. Escalates when timelines cannot be complete
    • Interact with drug manufacturer and packager during complaint investigations
    • Perform PQC case reconciliation with all involved vendors
    • Test TrackWise workflow and participate in review of procedures as they are adapted to TrackWise
    • Participate in the testing of the TrackWise system modules
    • Assist QA with the conduct of internal audits.
    • Assist quality personnel in activities to accomplish company goals.
    • Assist QA management in preparing process metrics and progress reports.
    • Propose process improvements related to the QA function.
    • Receives GSOPs from TPC and upload them into Master Control (MC)
    • Update Table of Contents for GSOPs
    • Maintain library books of procedures up-to-date
    • Upload, and  format, company procedures in MC
    • Launch SOPs, Guidances and WI in MC
    • Set effective date and Launching Training for all company employees
    • Assist in the execution of UAT, as needed
    • Perform other related duties as assigned.

    Qualifications

    Educational Requirements:   

    High school degree is mandatory, college degree preferred with at least three years related pharmaceutical/technical quality assurance or regulatory documentation experience, or equivalent experience.

     

    Experience: 

    • Considerable experience in a pharmaceutical industry working in a regulatory or quality assurance department.
    • Solid knowledge and experience on QA/QC processes.-
    • Solid knowledge in handling product complaints
    • Experience with tracking systems for product complaint, change control, and investigations.
    • Experience with Master Control and/or TrackWise system is a plus

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