Auditor and Compliance Specialist
1 month ago
About Us
Baxter Healthcare is a pioneering company in the field of kidney care, with a legacy spanning nearly 70 years. Our goal is to provide best-in-class care to patients worldwide.
At Baxter, you will become part of a community driven by focus, courage, and a commitment to excellence. We are revolutionizing kidney care and other vital organ support, and we invite talented professionals to join us on this journey.
Job Summary
We are seeking an experienced Auditor and Compliance Specialist to ensure the delivery of high-quality services and adherence to regulatory requirements. The successful candidate will be responsible for coordinating quality system requirements, investigating events, and driving change through recommendations.
This role offers a competitive salary of $85,000 - $110,000 per annum, depending on location and experience. Additional benefits include professional development opportunities, a strong work-life balance, and a commitment to growing and developing an inclusive and diverse workforce.
Key Responsibilities
- Coordinate the completion of quality system requirements and ensure timely implementation.
- Investigate events using root cause analysis tools and drive change through recommendations.
- Work with cross-functional teams to assure compliance with CAPA's, Change Controls, and site KPIs.
- Drive a culture of continuous improvement across all departments.
- Participate in internal and Global Compliance audits.
- Familiarize yourself with GMP, CAPA, Change Control, and Training Management Systems and deliver associated training.
- Actively work on Batch Release workload.
- Proactively identify and implement continuous improvement initiatives.
Requirements and Qualifications
- Science-based education.
- A minimum of 2 years' experience in a GMP manufacturing environment as QA.
- Demonstrated use of lean management tools.
- Knowledge and application of root cause investigation techniques.
- Experience leading change in own area of expertise and cross-functionally.
- Experience in training delivery and training processes.
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