• Quality Assurance Specialist

    Quality Assurance/Compliance
    US-NY-New York
  • Responsibilities

    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.


    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.



    • Investigate specific client complaints, adverse experiences and operational problems to identify root cause and design corresponding action plans.
    • Prepare client-facing formal Incident Reports as needed and drive completion and effectiveness.
    • Responsible for daily Compliance Management: review and approval, internal audits, vendor management
    • Collaborate with Vendor Management in updating linguist profiles, trend analysis, restrictions, recruiting needs, etc.
    • Implement, monitor, evaluate and develop quality assurance and quality control activities to ensure quality of products produced by TransPerfect group of companies worldwide
    • Actively maintain and improve awareness of QA processes, policies and procedures through training and documentation management
    • Analyze data for trends and make recommendations for process improvement
    • Assist CRO (Contract Research Organization) Program Management in preparing for client meetings, and effectiveness checks on CAPA items


    As a Quality Assurance you are:

    • 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
    • Exceptional problem solving/critical thinking skills and ability to learn new skills quickly
    • Superior organizational skills in order to meet commitments and deadlines
    • Able to multitask in a fast-paced environment
    • Work well with people from a variety of different backgrounds and cultures
    • Ability to adhere to and abide by the customer’s and company’s quality standards
    • Build relationships with clients and co-workers
    • Can work independently and as part of a team

    Your experience includes:

    • Minimum Bachelor’s degree
    • Superior written and spoken communication skills in English
    • Proficiency in Microsoft Office (Word, Excel, Outlook)
    • Experience with ISO 9001 and/or other international standards and regulations
    • Experience as QA in regulated industries

    A plus would be:

    • Experience with Six Sigma and other quality standard
    • Experience with ISO 17100 (EN 15038) and/or ISO 27001
    • Fluency in a foreign language
    • Experience in the Life Sciences industry, especially study documentation
    • Knowledge of clinical development phases and processes including GCP and ICH regulations and 21 CFR Part 11 requirements


    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.

    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 has global headquarters in New York, and regional headquarters in London and Hong Kong and offers a full range of services in 170+ languages to clients worldwide with an unparalleled commitment to quality and client service.


    For more information on the TransPerfect Family of Companies, please visit our website at


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