Quality Associate II

Job Responsibility:

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.

Position Summary

Join a team that values precision, innovation, and collaboration at Baxter Healthcare Corporation.

Responsibilities:

• Work closely with cross-functional teams, including IT, product management, engineering, and business collaborators, to establish quality goals and needs.
• Conduct risk assessments and identify potential areas for improvement in digital systems, processes, and workflows, partnering with IT as needed based on system architecture.
• Provide frontline day-to-day support on product quality issues to ensure GMP, regulatory, and procedural compliance, maintaining flawless standards of quality.
• Support during assigned shifts, including the requirement to support plant overtime and planned shutdowns when applicable, with the flexibility to cover other shifts as necessary.
• Provide technical support on review/approval of department-related procedural changes, product quality issues, reinspection, new product introduction, and protocols.
• Ensure timely follow-up on quality exceptions and their preventative/corrective actions.
• Initiate, investigate, and approve non-conformance events in the Trackwise system.
• Serve as the SME for Electronic Batch Record (EBR) and Statistical Process Control (SPC) systems.
• Perform change control assessments, executions, and approvals.
• Support Quality IT Systems (SPC Infinity, EBR, BMTCS, Maximo, etc.).
• Maintain control of defective WIP materials (quarantine, retention, and disposal areas) to align with regulatory and compliance requirements.
• Maintain data on critical metrics for Quality operations and Management review.
• Train, mentor, and guide Associates I to achieve defined quality goals and results, facilitating development and ensuring compliance with set standards.
• Use trending reports of quality exceptions to partner with production personnel, determining opportunities to improve processes and reduce exceptions.
• Support complaint and CAPA investigations as required.
• Conduct documentation reviews and approvals in the plant for compliance with existing procedures and instructions, verifying the efficiency of these procedures against Baxter Corporate and Regulatory Requirements.
• Maintain Alliston files in accordance with the Quality Retention Policy.
• Support and lead the weekly/daily Tier/Release meetings to present quality and compliance issues.
• Lead and participate in continuous improvement projects aimed at achieving quality, reliability, and cost improvement goals.
• Act as SME for assigned processes during internal/external audits with regulatory authorities.
• Support an audit-ready state by performing GEMBAs and following up with area owners to ensure the timely closure of observations, working with operations to remediate issues.
• Act as a delegate for the Quality Operations Manager when required.
• Perform other tasks as assigned.

Knowledge, Skill and Abilities

• Detailed knowledge of drug regulations and standards.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent communication and leadership abilities.
• Strong interpersonal, influencing, and negotiation skills.
• Proven project management skills.
• Ability to analyze risk and make informed decisions.

Required Education and Experience

• Bachelor's degree in engineering, biochemistry, microbiology, or a related field; a master's degree is preferred.
• A minimum of 3 years of experience in quality assurance.
• Experience in project management.

Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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