QA Auditor (Life Sciences) (Provincia de Buenos Aires)

QA Auditor (Life Sciences) (Provincia de Buenos Aires)

16 sep
|
Transperfect
|
Provincia de Buenos Aires

16 sep

Transperfect

Provincia de Buenos Aires

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 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.

In order to apply, please submit your CV in English

Position responsibilities:

- Conduct and support internal, customer, supplier, regulatory, and certification audits.
- Ensure compliance with international and local regulations and standards, including ISO 9001, ISO 17100, and GxP.
- Coordinate and host customer audits, working closely with clients, auditors, vendors, and internal stakeholders.
- Manage audit findings and coordinate corrective and preventive actions (CAPA) through resolution.
- Investigate findings and operational issues to identify root causes and improvement opportunities.




- Analyze audit data and prepare trend reports and insights for management.
- Support the development and continuous improvement of QA programs, policies, processes, and procedures.
- Build strong relationships with clients, auditors, and internal teams.
- Stay up to date with regulatory and industry standards, particularly those relevant to regulated industries.
- Travel domestically and internationally as required.

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

📌 QA Auditor (Life Sciences) (Provincia de Buenos Aires)
🏢 Transperfect
📍 Provincia de Buenos Aires

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