Quality Associate II (Audit),

About the role

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.

Responsibilities

• Maintains Compliance Audit Quality Systems in accordance with applicable regulatory requirements.
• Manages the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for audits performed.
• Prepares for and conducts internal and supplier audits by researching background information and developing assessment strategy; collects and analyzes objective evidence regarding issues and risks.
• Reports audit/inspection findings to management and evaluates audit responses, CAPA plans, and CAPA objective evidence for adequacy, including root cause determination and timeliness; escalates issues to management as appropriate.
• Manages audit files through the process to closure and performs follow-up audits to confirm CAPA effectiveness.
• Captures and coordinates state licensing program.
• Supports external regulatory inspections including back room management, document retrieval, and commitment tracking through closure.
• May serve as front room host/table lead.
• Prepares management reports depicting compliance trends for Management Review purposes.
• Mentors and trains Quality Compliance Associates I and Technicians on audit methodology and compliance procedures.
• Supports continuous improvement initiatives and quality system enhancement projects.
• Serves as a knowledgeable resource for internal audits, external inspection support, state licensing, and regulatory intelligence activities.

Requirements

• Candidate must not be allergic to Penicillins or Cephalosporins.
• BS in business or science or equivalent degree.
• Minimum 3 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
• Minimum 3 years of related quality auditing experience in cGMP environments; previous internal or external auditing experience required.
• AQSC CQA and/or other auditor accreditation strongly preferred.
• Extensive working knowledge of applicable quality and regulatory standards and regulations.
• Excellent communication skills – both written and oral – with ability to present to management.
• Demonstrated sound judgment and analytical skills to enable assessment of risk.
• Expertise in GMP regulations and regulatory inspection processes.
• Strong organizational skills with ability to lead multiple complex projects.
• Proficiency in quality software systems (e.g., TrackWise) and MS Office applications.
• Resourceful, self-reliant, self-motivated, and confident.

Qualifications

• General knowledge of Lean Six Sigma and other continuous improvement tools preferred.

Skills

• Quality Assurance
• Quality Control
• Regulatory Compliance
• Internal Auditing
• External Inspection Support
• State Licensing
• Regulatory Intelligence

Benefits

The estimated base salary for this position is $88,000 to $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Pay

The estimated base salary for this position is $88,000 to $121,000 annually.

Schedule

Not specified.