Quality Assurance Specialist
Listed on 2026-10-03
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Quality Engineering
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives.
Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.
As a Quality Assurance Specialist, you will play a key role in ensuring that our plant activities are carried out in line with GMP requirements and company quality policies. Working closely with cross-functional teams, you will lead quality investigations, drive corrective actions and training, support supplier qualification activities, and help ensure our site remains aligned with regulatory and quality requirements. This is an excellent opportunity for someone who enjoys solving problems, collaborating across departments, and influencing positive change.
Whatyou will be doing
- Be responsible for the functional activities associated with the creation, review, distribution and archiving of quality records in accordance with Good Documentation Practices guidelines.
- Lead non-conformity investigations and corrective action plans, identifying root causes and implementing sustainable solutions to prevent recurrence and strengthen product quality.
- Drive supplier qualification and supplier quality activities, ensuring suppliers meet Baxter's quality expectations.
- Support internal and external audits, helping ensure ongoing compliance and readiness for inspections.
- Provides training and coaching in their respective areas of expertise, helping employees understand their responsibilities and maintain high compliance standards.
- Review and update quality policies, procedures, and the Quality Manual, keeping the Quality Management System aligned with Business requirements.
- Manage electronic quality documentation processes, ensuring records are accurate, controlled, and accessible to support compliance and operational efficiency.
- Partner with departments across the site to keep processes current and effective, ensuring procedures reflect standards and regulatory expectations.
- Promote a culture of continuous improvement, finding opportunities to enhance processes, increase efficiency, and strengthen overall quality performance.
- Experience working with Quality Management Systems, ideally within the pharmaceutical, medical device industries and solid understanding of Good Manufacturing Practices (GMP) and/or ISO 13485 requirements.
- Degree in Engineering or Scientific field preferred, or equivalent experience considered.
- Proven experience managing investigations, corrective actions.
- Ability to operate in compliance with safety standards and internal Quality procedures.
- Strong communication and collaboration skills, with the ability to work effectively across different teams.
- A proactive approach with strong problem-solving capabilities.
- Good level of English and Italian.
Competitive salary according to experience. Purposeful work where your contribution directly supports healthcare professionals and patients. A collaborative and supportive culture that values teamwork and continuous improvement. Career development opportunities within a global healthcare leader operating in more than 100…
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