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QA Auditor

TransPerfect

This is a Full-time position in New York, NY posted July 18, 2021.

The Quality Assurance (QA) Department is an independent, neutral branch of TransPerfect.

The goals of the department are simple: look out for TransPerfect’s and TransPerfect’s customers’ best interests and promote and improve quality.

The QA 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 QA Auditor is responsible for ensuring customer satisfaction and retention by carrying out compliance and audit-related tasks as well as providing follow-up activity with customers, auditors, vendors or other forms of quality and process inspections.

A QA 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.

Responsibilities:
Managing and coordinating customer inspections ((re)qualification forms, remote and onsite audits) and associated communication, audit programs and schedules.

Managing and resolving customer audit follow up assignments within required timeframes.

Reviewing effectiveness of CAPA, resulted from customer audits, on a scheduled basis.

Support of management review to collate and present customer audit data.

Hosting registrar and regulatory inspections, as needed.

Conduct internal and other independent ad-hoc audits (customer, department, process), as needed.

Assisting in continual improvement and development of new procedures to foster TQM and develop current QMS (including associated technology improvement requests).

This includes reviewing and continually improving customer audit process for efficiencies.

Assisting with RFI/RFP coordination and completion, as needed.

Building and maintaining strong relationships with new and established audit customers.

Assist the Compliance & Privacy Officer and QA Director with the creation, documentation, implementation, and evaluation of internal quality assurance programs in order to maintain accreditation.

Maintaining professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

Travel domestically and internationally, as required.

About You:

As a QA 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 or its equivalent 10 years experience in Quality Assurance and auditing, incl.

experience with ISO 9001 and/or ISO 27001 and 21 CFR Part 11 and GCP/ICH.

Additional international standard and regulation experience (such as ISO 17100 (EN 15038)) may be preferred Experience as QA in regulated industries (such as Finance, Healthcare, Pharmaceutical, CRO, Medical Device, Investigative Site, etc.) 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 applications (Word, Excel, Outlook) Ability to work under own initiative

About Us:

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 $850 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 TransPerfect Family of Companies, please visit our website at .