Quality Associate II (Audit)

Baxter International Inc.•Round Lake, IL

5d•$88,000 - $121,000•Onsite

About The Position

This role is for a Quality Associate II (Audit) at Baxter, a company dedicated to redefining healthcare and helping people live healthy lives. The position is within the Quality department, where every role contributes to ensuring the quality of products shipped worldwide. The Quality function values teamwork and independence, fostering a collaborative environment where employees are empowered to bring creativity to problem-solving and continuous improvement. The mission of Baxter, to save and sustain lives, is paramount, with quality always taking precedence over quantity. The team is built on shared traits of reliability, ethics, and care, encouraging open dialogue and accountability to create better products for customers.

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.
Extensive working knowledge of applicable quality and regulatory standards and regulations.
Excellent communication skills – both written and oral – with ability to present to management.
Must demonstrate 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.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

ASQ CQA and/or other auditor accreditation strongly preferred.
General knowledge of Lean Six Sigma and other continuous improvement tools preferred.

Responsibilities

Independently manage compliance audit processes and serve as a knowledgeable resource for internal audits, external inspection support, state licensing, and regulatory intelligence activities.
Lead routine compliance investigations, contribute to metrics analysis and trend reporting, and support inspection readiness while mentoring junior team members on audit methodology and compliance expectations.
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.
Coordinates and manages state licensing program.
Leads regulatory intelligence activities including analysis and distribution of FDA guidance, warning letters, consent decrees, and industry publications to relevant stakeholders.
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.
Participates in continuous improvement initiatives and quality system enhancement projects.
Supports customer compliance activities including customer audits and customer regulatory information requests.

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits