Senior Process SME

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

To provide and facilitate subject matter expertise (systems, processes, and equipment) to the compounding team at NW Operations in the support of Quality investigations.

Essential Duties and Responsibilities

• Quality champion in the Operations team, conduct investigations to support the Operations and NW leadership team to complete on time, determine root causes, CAPA’s, any change controls

• Completion of Operational investigations within the QMS in conjunction with Quality, Operations, Engineering, Sterility Assurance, Training colleagues

• Risk assessing quality incidents in collaboration with QA

• Attend and participate in the Compliance meetings and QMR

• Use DMAIC tools and ensure effective and timely communication to impacted stakeholders.

• Support Internal Audits in line with the Internal Audit Schedule.

• Support Corporate, external Regulatory and Customer audits through provision of requested documentation, records and information in a timely manner.

• TrackWise 8 NCR/CAPA/CQI/CPI (TW8) System User

• Fully support the Quality Policy and Business Objectives by building quality in to all aspects of work at NWU

• Conduct Manufacturing Impact Assessments within the TrackWise 8 (TW8) Change Control process

Education and/or Experience

• Excellent interpersonal skills with ability to interface well with other departments.

• Must have knowledge of such principles as GMPs, cleanroom requirements and automation.

• Must be self-motivated, have good interpersonal skills, capable of analyzing and solving problems through innovative thought and experience.

• Ability to collaborate with cross-functional teams simultaneously.

• Experience of QMS and GMP in a regulated industry.

• Aseptic manufacturing environment experience, familiarity with EU GMP Annex 1 preferred.

• Knowledge of isolator, RABS and VHP technology preferred.

What are some of the benefits of working at Baxter?

• Competitive total compensation package

• Professional development opportunities

• High importance placed on work life balance

• Commitment to growing and developing an inclusive and diverse workforce

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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