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 General 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 **** and ISO *****.
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 schedulesPerform all auditing activities comply with relevant standards and regulations (ISO ****, ISO *****, GxP etc.)Host, manage and coordinate customer audits and qualification activities, including communications and outcomesCoordinate preparation for and hosting of customer audits, including allocation of internal resourcesManage and resolve customer audit findings, corresponding action items, and follow-up assignments within required timeframesBuild and maintain strong relationships with new and established client auditors, representatives and internal stakeholdersAssist with RFI/RFP coordination and completion, as neededConduct and support calls with customer auditors and quality representativesCo-host and/or support registrar and regulatory inspections or assist in closure activities, as requiredConduct and support QA internal and independent ad-hoc audits, as neededConduct and support TransPerfect's non-linguistic supplier qualification, as neededAssist QA Management in creation, documentation, implementation,



and evaluation of internal QA programs to maintain accreditation and certificationInvestigate audit findings, adverse experiences, and operational problems to identify root causes and implement effective corrective and preventive actions (CAPA), ensuring alignment with corporate processesReview effectiveness of CAPA resulting from customer, supplier, QA Internal or other related auditsUtilize auditing platforms to analyze findingsMaintain all internal trackers and technologies used in the QA audit processesPrepare and present periodic trend analysis reports to managementSupport management review by analyzing, collating and presenting QA audit dataConsult project teams on resolution of audit findings, ensuring proper and timely audit resolutionContribute to continuous improvement and development of procedures to foster Total Quality Management (TQM) and enhance the Quality Management System (QMS), including technology enhancementsMaintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societiesStay current with regulatory and industry standards relevant to QA in regulated industriesHandle additional duties and special projects to ensure efficient, effective, and compliant business operationsMaintain audit integrity, ethical judgment and risk-based thinking in all audit practicesContribute to team efforts by accomplishing related results, as neededTravel domestically and internationally, as requiredComplete all other tasks that are deemed appropriate for the role and assigned by the manager/supervisorEssential skills and experience required:Innovative, proactive,



and resourceful; committed to quality and continuous improvementAbility to adhere to both customer and company quality standards and requirementsExceptional problem-solving and critical-thinking skills, with the ability to learn new skills quicklyStrong organizational and multi-tasking skills to meet commitments and deadlinesExcellent written and verbal communication skills in EnglishProven ability to manage multiple projects and audits simultaneously in a fast-paced environmentFacility to work effectively with diverse teams and across cultureBuild relationships with customer and co-workersAbility to work independently and collaboratively in a team environmentProficiency in Microsoft Office suiteAbility to work independently and take initiativeAbility to maintain professionalism in all situationsMinimum Bachelor's degree or its equivalentExperience with ISO ****, ISO ***** (EN *****) and/or ISO ***** and/or other international standards and regulationsPrevious experience overseeing sponsor audits, internal, and/or regulatory inspection auditsExperience in Quality Assurance, CAPA, change control, deviation management, complaint handling, and regulatory complianceMinimum of two (2) years of experience in the Life Sciences industry, including experience with QA related audits, clinical study documentation, and eClinical technologies Desired skills and experience:Experience with ISO ***** (EN *****) and/or ISO ***** and/or other international standards and regulationsExperience as QA in regulated industries (such as Finance, Healthcare, Pharmaceutical, CRO, MedicalDevice, Investigative Site, etc.)Experience with Six Sigma, Lean, and other quality standardsLead Auditor Certification in relevant ISO standards (ISO ****, ISO*****, etc.)Fluency in a foreign language other than English is a plusKnowledge 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 requirementsPrevious experience overseeing sponsor audits, internal, and/or hosting regulatory inspectionsIn order to apply, please submit your CV in English

📌 Qa Auditor (Buenos Aires)
🏢 Transperfect
📍 Buenos Aires