TransPerfect

  • Quality Assurance Specialist

    ID
    2017-8901
    Category
    Quality Assurance/Compliance
    Location
    US-NJ-Princeton
  • Responsibilities

    Summary:

    The Quality Assurance (QA) Department is an independent, neutral branch of TransPerfect that reports directly to TransPerfect’s CEO. The goals of the department are simple: ensure TransPerfect’s and TransPerfect’s clients’ best interests and promote and improve quality.

    The Quality Assurance Specialist directly impacts all aspects of TransPerfect’s Global Quality Management System, which is compliant to all applicable international and local statutory and regulatory requirements (e.g., 21 CFR Part 11 and GCP/ICH) as well as international standards such as ISO 9001 and ISO 17100 (EN 15038). The Quality Assurance Specialist plays a vital role in the maintenance, establishment and development of Quality Assurance programs, policies, processes and procedures as well as in ensuring client satisfaction and retention by carrying out audit-related tasks and follow-up activity with clients, auditors, vendors or other forms of quality and process inspections, as needed.

    A Quality Assurance Specialist must be a change agent that will foster a quality-driven culture, promote innovative practices that ensure quality and success, and integrate quality practices and accountability into all activities.

    Responsibilities:

    • Investigate specific client complaints / adverse experiences / operational problems to identify root cause and design effective corrective and preventive actions
    • Prepare and provide formal Incident Reports for clients, as needed
    • Responsible for daily Compliance Management - review and approval, internal audits
    • Collaborate with Vendor Management in updating linguist profiles, trend analysis, restrictions, recruiting needs, etc.
    • Assist with Document Management—review and approval as well as training records management
    • Actively maintain and improve awareness of QA processes, policies and procedures through training and other applicable methods
    • Implement, monitor, evaluate and develop quality assurance and quality control activities to ensure quality of products produced by TransPerfect group of companies worldwide
    • Assist CRO (Contract Research Organization) Program Management in preparing for client meetings, and effectiveness checks on CAPA items
    • Prepare monthly quality reports for production teams
    • Assist with quality related administrative requests/data output from various employees
    • Participate in client audits, including related client meetings, calls, and other communication (drafting client letters, reports, and other client-facing materials), as needed
      • This includes leading and/or assisting preparation, investigation, reports and any other pre/post audit activities
      • Liaison with all people involved in such audits
      • Investigate findings or adverse experiences and operational problems to identify root cause and effective corrective and preventive actions

    Qualifications

    About You:

    As a Quality Assurance Specialist you are a:

    • Creative thinker – You are curious and unafraid to ask questions
    • Hard worker – You are industrious and diligent in everything you do
    • Innovator – You are willing to initiate changes and introduce new ideas

    Your experience includes:

    • Ability to adhere to and abide by the customer’s and company’s quality standards
    • Exceptional problem solving/critical thinking skills and ability to learn new skills quickly
    • Superior organizational and multi-tasking skills in order to meet commitments and deadlines
    • Superior written and spoken communication skills in English
    • Proficiency in Microsoft Office (Word, Excel, Outlook) Minimum Bachelor’s degree or its equivalent
    • Experience with ISO 9001 and/or other international standards and regulations Experience with ISO 17100 (EN 15038) and/or ISO 27001
    • Experience as QA in regulated industries (such as Finance, Healthcare, Pharmaceutical, CRO, Medical Device, Investigative Site, etc.)
    • Experience with Six Sigma and other quality standards
    • Fluency in a foreign language
    • Able to multitask in a fast-paced environment
    • Work well with people from a variety of different backgrounds and cultures
    • Build relationships with clients and co-workers
    • Can work independently and as part of a team
    • For those specializing in Life Sciences, knowledge of clinical development phases and processes including GCP and ICH regulations and 21 CFR Part 11 requirements; experience in overseeing and training employees on TMF SOPs and regulatory requirements; and, previous experience overseeing sponsor audits, internal, and/or regulatory inspection audits

    Overview

    For more than 25 years, TransPerfect has provided comprehensive language and technology solutions to help our clients communicate and conduct business more effectively in a global marketplace. Equipped with a quality management system certified to both the ISO 9001:2015 and ISO 17100:2015 standards, TransPerfect provides a full array of language and business support services, including translation, interpretation, multicultural marketing, website globalization, subtitling, voiceovers, staffing services, e-learning and training, and legal support services. TransPerfect also offers a suite of next-generation technologies that significantly reduce costs and improve consistency throughout the translation process, making TransPerfect the vendor of choice for the world's leading multinationals.

     

    TransPerfect Life Sciences Solutions has helped life sciences companies conduct clinical development and commercialize products on a global scale. We bring that same level of expertise to our secure, web-based e-clinical solution, Trial Interactive. Trial Interactive enables life sciences companies to streamline the execution and commercialization of global clinical trials and collaborate on partnerships while reducing administrative burdens. 

    With annual revenues of over $615 million, TransPerfect is the world's largest provider of language services and technology solutions. From offices in more than 90 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

     

    For more information on the Trial Interactive, please visit our website at www.trialinteractive.com.

     

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