Quality Associate-II, QA Assurance

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.

Within Quality, every role matters. Baxter’s products are shipped worldwide to patients in need. Whether you build new processes or solve unique production challenges, you have the trust and chance to bring creativity. No matter your role, your work will impact part of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to build top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps develop a better product for our customers.

• Provide front line day-to-day assistance on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality.
• Support during assigned Shift, with the requirement to support plant overtime and planned shutdowns when applicable.
• Provide technical assistance on review and approval of department-related procedural changes, product quality concerns, reinspections, new product introductions, and protocols.
• Support timely follow-up on quality exceptions and their preventative/corrective actions.
• Support initiation/investigation and approvals of non-conformance events in the Trackwise system.
• Act as SME for Electronic Batch Record (E ) and SPC or equivalent experience.
• Perform change control assessments/executions and approvals.
• Ensure control of defective WIP materials (quarantine, retention, and disposal areas) to keep segregation, movement, documentation, and timely follow-up within the plant in sync with regulatory and compliance requirements.

Required:

• University Degree or equivalent experience, Bachelor of Science or equivalent experience.
• 1 – 3 years’ experience in manufacturing and quality roles.
• Prior experience working in a GMP setting.
• Knowledge of cGMP, ISO, and regulatory standards.
• Diligent with the ability to work effectively under pressure.
• Strong written and verbal communication abilities, negotiation capabilities, and the capacity to collaborate with individuals at every level of the organization.
• Ability to build positive relationships and partner with internal and external collaborators.
• Strong ability to balance multiple priorities.
• Strong analytical and problem-solving skills with critical thinking abilities.
• Intermediate to Advanced proficiency in MS Office Suite.

• 3+ years with exposure to various areas of the manufacturing environment.
• Experience in pharmaceutical, healthcare, or food manufacturing environments.
• Experience with continuous improvement methodologies, Lean 6S, Kaizen, TPM, DMAIC.

Join us in our mission to make a global impact with your outstanding skills and dedication…