Quality Associate-II, QA Assurance

What you'll be doing

• 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.

• University Degree or equivalent experience, Bachelor of Science or equivalent.
• 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.

The estimated salary range for this position is $86,400 - $129,600 annually. Individual pay will be determined based upon skills, experience and performance under the Management Incentive Compensation Plan.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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