TransPerfect

Quality Auditor

ID
2017-9253
Category
Quality Assurance/Compliance
US-NY-New York

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: look out for TransPerfect’s and TransPerfect’s clients’ best interests and promote and improve quality.

 

The Quality Auditor 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. They play a vital role in the maintenance, establishment and development of Quality Assurance programs, policies, processes and procedures. The Quality Auditor is responsible for ensuring client satisfaction and retention by carrying out compliance and audit-related tasks as well as providing follow-up activity with clients, auditors, vendors or other forms of quality and process inspections.

 

A Quality Auditor 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. Travel up to 20% as required.

Responsibilities:

  • Client Support
    • Complete all quality and technology aspects of RFI/RFP process
    • Responds to client questions and attends client meetings
    • Prepares internal resources for client audits
    • Host client audits
  • Compliance
    • Conduct internal audits to review compliance with internal, industry, and regulatory standards
    • Investigate client complaints or adverse experiences to identify root cause and propose effective corrective and preventive actions; provide the formal Incident Report back to the client
    • Investigate operational problems to identify root cause and propose effective corrective and preventive actions
    • Manage compliance program
    • Host registrar and regulatory inspections
  • Vendor Management
    • Host vendor audits to review vendor QMS implementation and adherence to industry and regulatory standard
    • Oversee vendor quality trends and implement appropriate corrective and preventive actions

Qualifications

About You:

As an Quality Auditor 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:

  • Minimum Bachelor’s Degree from a 4-year college or university
  • Minimum of 3 years of experience in the Life Sciences industry
  • 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)
  • Knowledge of ISO 9001:2008 and/or ISO 17100
  • Knowledge of clinical development phases and processes including GCP and ICH regulations and 21 CFR Part 11 requirements
  • Previous experience overseeing sponsor audits, internal, and/or regulatory inspection audits

Overview

About Us:

For more than 20 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, multicultural marketing, 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 $550 million, TransPerfect is the world's largest privately held 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 TransPerfect Family of Companies, please visit our website at www.transperfect.com.

 

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