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Transperfect Translations International, Inc. QA Auditor in NEW YORK, New York

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