Talent Quality & Process Auditor — Remote & Flexible Hours

BairesDev; Buenos Aires; Hybrid; ARS 90,873,000 - 121,164,000; Full time

Job summary

TransPerfect is seeking a Quality Assurance Auditor to independently support the Global QMS, ensuring compliance with ISO standards and local regulations. You will conduct compliance audits, drive CAPA activities, and collaborate with clients, auditors and internal teams.

The role emphasizes strong English communication, two years in Life Sciences QA audits, and a Bachelor’s degree. You will participate in audit programs, support regulatory inspections, and contribute to continuous quality

Qualifications

• Excellent written and verbal communication skills in English.
• Experience with ISO 9001, ISO 17100 and/or ISO 27001 and related standards.
• Minimum of two years in Life Sciences QA audits.
• Bachelor’s degree or equivalent.
• Ability to manage multiple audits in a fast-paced environment.

Responsibilities

• Develop and execute audit programs and schedules.
• Perform audits in compliance with relevant standards (ISO 9001, ISO 17100, GxP).
• Host and coordinate customer audits and qualification activities.
• Prepare for and host customer audits with internal resources.
• Manage audit findings and follow-up actions within deadlines.
• Build relationships with clients, auditors and internal stakeholders.
• Assist with RFI/RFP coordination and QA programs evaluation.
• Conduct QA internal and supplier audits as needed.
• Maintain QA documentation and QA program effectiveness.

Skills

Excellent communication in English

QA audits & CAPA experience

Regulatory compliance knowledge

Life Sciences QA background

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

Quality Assurance Auditor

The Quality Assurance (QA) Department functions as an independent, objective division within TransPerfect, dedicated to advocating for the organization’s best interests through the promotion and continuous enhancement of quality standards.

The Quality Assurance Auditor exerts direct influence over all facets of TransPerfect’s Global Quality Management System (QMS), ensuring adherence to relevant international and local statutory and regulatory frameworks as well as compliance with globally recognized standards such as ISO 9001 and ISO 17100. The QA Auditor is integral to the development, implementation, and ongoing improvement of QA programs, policies, processes, and procedures.

Key responsibilities include ensuring customer satisfaction and retention by conducting compliance audits, facilitating remediation activities, and coordinating with clients, auditors, vendors, and other relevant stakeholders.

Position responsibilities:

Participate in the development and execution of audit programs and schedules

Perform all auditing activities comply with relevant standards and regulations (ISO 9001, ISO 17100, GxP etc.)

Host, manage and coordinate customer audits and qualification activities, including communications and outcomes

Coordinate preparation for and hosting of customer audits, including allocation of internal resources

Manage and resolve customer audit findings, corresponding action items, and follow-up assignments within required timeframes

Build and maintain strong relationships with new and established client auditors, representatives and internal stakeholders

Assist with RFI/RFP coordination and completion, as needed

Conduct and support calls with customer auditors and quality representatives

Co-host and/or support registrar and regulatory inspections or assist in closure activities, as required

Conduct and support QA internal and independent ad-hoc audits, as needed

Conduct and support TransPerfect’s non-linguistic supplier qualification, as needed

Assist QA Management in creation, documentation, implementation, and evaluation of internal QA programs to maintain accreditation and certification

Investigate audit findings, adverse experiences, and operational problems to identify root causes and implement effective corrective and preventive actions (CAPA), ensuring alignment with corporate processes

Review effectiveness of CAPA resulting from customer, supplier, QA Internal or other related audits

Utilize auditing platforms to analyze findings

Maintain all internal trackers and technologies used in the QA audit processes

Prepare and present periodic trend analysis reports to management

Support management review by analyzing, collating and presenting QA audit data

Consult project teams on resolution of audit findings, ensuring proper and timely audit resolution

Contribute to continuous improvement and development of procedures to foster Total Quality Management (TQM) and enhance the Quality Management System (QMS), including technology enhancements

Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies

Stay current with regulatory and industry standards relevant to QA in regulated industries

Handle additional duties and special projects to ensure efficient, effective, and compliant business operations

Maintain audit integrity, ethical judgment and risk-based thinking in all audit practices

Contribute to team efforts by accomplishing related results, as needed

Travel domestically and internationally, as required

Complete all other tasks that are deemed appropriate for the role and assigned by the manager/supervisor

Essential skills and experience required:

Excellent written and verbal communication skills in English

Minimum Bachelor’s degree or its equivalent

Experience with ISO 9001, ISO 17100 (EN 15038) and/or ISO 27001 and/or other international standards and regulations

Previous experience overseeing sponsor audits, internal, and/or regulatory inspection audits

Experience in Quality Assurance, CAPA, change control, deviation management, complaint handling, and regulatory compliance

Minimum of two (2) years of experience in the Life Sciences industry, including experience with QA related audits, clinical study documentation, and eClinical technologies

Proven ability to manage multiple projects and audits simultaneously in a fast-paced environment

Innovative, proactive, and resourceful; committed to quality and continuous improvement

Ability to adhere to both customer and company quality standards and requirements

Exceptional problem-solving and critical-thinking skills, with the ability to learn new skills quickly

Ability to work independently and collaboratively in a team environment

Proficiency in Microsoft Office suite

Desired skills and experience:

Experience with ISO 17100 (EN 15038) and/or ISO 27001 and/or other international standards and regulations

Experience as QA in regulated industries (such as Finance, Healthcare, Pharmaceutical, CRO, Medical

Experience with Six Sigma, Lean, and other quality standards

Fluency in a foreign language other than English is a plus

Knowledge of clinical development phases and processes including ICH E6, 21 CFR Part 11 requirements, GxP;

Experience in overseeing and training employees on QA SOPs and regulatory requirements

Previous experience overseeing sponsor audits, internal, and/or hosting regulatory inspections