Mitsubishi Tanabe Pharma

  • Associate, Quality Assurance (Contract)

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1259
    # of Openings
    1
    Category
    Quality Assurance
  • Overview

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma America, Inc. (MTPA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation, is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

     

    With the recent FDA approval and availability in the U.S. of RADICAVA® (edaravone) MTPA is rapidly expanding our operation across all functional areas to launch this new product in the U.S. market. Concurrently, the company is expanding its research efforts and exploring collaborations with partners to discover and bring treatments to market for unmet medical needs including orphan diseases. We currently seek motivated professionals who share our vision of scientific excellence, innovation, and unwavering dedication to improving the lives of patients. 

    The Associate, Quality Assurance is responsible for supporting Quality Assurance (QA) and Compliance related operational activities with a specific focus on QA documentation (e.g., quality complaints, change control documents, SOP’s, investigations, and other ad hoc cross-category initiatives.

    Responsibilities

    • Reviews product batch records to identify and resolve atypical occurrences.
    • Prepares, reviews and/or maintains a range of other QA documentation as required (e.g., annual product review reports, change control logbooks, training records, quality data binders, directories, databases, etc.).
    • Ensures documents are completed, signed, and date stamped prior to filing or uploading to databases in accordance with MTPA quality systems SOPs.
    • Initiates and assists with reviewing product quality complaints to determine product impact. Facilitates the closure of complaints in a timely manner.
    • Maintains the complaint data base to prepare and report on metrics for review.
    • Identify trends in Quality Systems and react accordingly to drive positive outcomes.
    • Authors and reviews new and existing SOP’s to further enhance and mature the Quality System.
    • Liaises with service providers, MT Pharma Corporate QA and functional stakeholders on a range of QA activities in particular as it relates to the product quality complaint process.
    • Evaluates and enhances departmental and company and/or vendor site quality procedures to ensure compliance with CGMPs and company policies; communicates any compliance issues to Senior QA Director as they arise.
    • Prepares yearly audit schedule; performs audit preparation activities for supplier, regulatory, and corporate CGMP audits.
    • Prepares, maintains and distributes, as appropriate, monthly reports, quality trend analysis/quality scorecards, trending charts, and meeting minutes.
    • Maintains and keeps track of files, including SOPs, product disposition documents, non-conformance investigations, extension requests, audits and CAPA.
    • Participates on project teams or on-site meetings as directed by QA Director.
    • Performs other duties as required.

    Qualifications

    • Bachelor’s degree, preferably in chemistry, biology, pharmacy or related scientific discipline
    • Minimum of 2 - 4 years QC/QA experience in a CGMP pharmaceutical environment encompassing change controls, training, complaints, nonconformance investigations, CAPA documents and data management
    • Experience working with service providers and in a matrix organization
    • Experience working with paper and electronic based documentation
    • Experience in preparation of quality score cards and monthly departmental reports
    • Experience in parenteral manufacturing is preferred but not required
    • Understanding of pharmaceutical drug product development and manufacturing
    • Ability to work independently with limited supervision
    • Knowledge of US FDA CGMPs and other regulatory guidance
    • Excellent interpersonal, communication and technical writing skills
    • Proficiency with computer programs such as Excel, Access, PowerPoint, SAP, ISO-Train, Track-Wise or other similar computer databases

    Physical Demands

    • Lift and pull up to 15 pounds
    • Carry, handle and reach for objects
    • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
    • Ability to sit or stand for long periods of time

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