Quality & Compliance Auditor - BA

TransPerfect Inc; Buenos Aires; Híbrido; ARS 90.547.000 - 135.820.000; Jornada completa

Descripción de la vacante

TransPerfect Inc. seeks a Quality Assurance Auditor to oversee the company’s QMS, ensuring compliance with ISO 9001, ISO 17100, ISO 27001, and regulatory requirements.

The role drives audit programs, host client audits, investigate findings, and lead corrective actions across global operations. Ideal candidates bring at least 2 years in Life Sciences QA, strong English communication, and proficiency in CAPA, change control, and regulatory compliance, with MS Office expertise.

Formación

• Excellent written and verbal communication in English.
• Bachelor’s degree or equivalent.
• Experience with ISO 9001, ISO 17100 (EN 15038) and/or ISO 27001 and/or other international standards and regulations.
• Overseeing sponsor audits, internal and/or regulatory inspections.
• Experience in QA, CAPA, change control, deviation management, complaint handling, and regulatory compliance.
• Minimum 2 years in Life Sciences with QA audits, clinical study documentation, and eClinical technologies.
• Proficient in Microsoft Office suite.

Responsabilidades

• Participate in development and execution of audit programs and schedules.
• Perform audits in compliance with ISO 9001, ISO 17100, GxP and related standards.
• Host, manage and coordinate customer audits and qualification activities.
• Coordinate preparation for and hosting of customer audits and allocation of internal resources.
• Manage and resolve audit findings and action items within set timeframes.
• Build relationships with client auditors and internal stakeholders.
• Assist with RFI/RFP coordination as needed.
• Conduct and support calls with customer auditors and QA representatives.
• Co-host registrar and regulatory inspections or assist in closures.
• Conduct internal and ad-hoc QA audits as needed.
• Assist QA Management in internal QA programs to maintain accreditation.
• Investigate audit findings to identify root causes and implement CAPA.
• Review CAPA effectiveness from audits.
• Utilize auditing platforms to analyze findings and maintain trackers.
• Prepare periodic trend analysis reports for management.

Conocimientos

English proficiency

Bachelor degree

ISO 9001

ISO 17100

ISO 27001

QA audits

CAPA & deviation

Life Sciences

MS Office

Educación

Bachelor's degree or equivalent

Descripción del empleo

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

• Device, Investigative Site, etc.)

• Experience with Six Sigma, Lean, and other quality standards

• Lead Auditor Certification in relevant ISO standards (ISO 9001, ISO27001, etc.)

• 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