Quality Associate II (Audit)

Baxter•Round Lake, IL

4d•Onsite

About The Position

This role is for a Quality Associate II (Audit) at Baxter, a company dedicated to redefining healthcare delivery and making a greater impact on global health. The position is ideal for a creative, thorough, and detail-oriented individual who thrives on diverse challenges and is motivated by work that is consistently evolving. As a Quality Associate II, you will be responsible for navigating internal processes, absorbing and acting on complex procedures and data, and potentially training peers. The role emphasizes getting tasks done efficiently without compromising safety or quality. The Quality function at Baxter is crucial for ensuring the integrity of products shipped worldwide to patients in need. Team members are trusted to bring creativity to problem-solving and are empowered to make a meaningful impact. The company culture values collaboration, reliability, ethics, and care, fostering an environment where open dialogue and accountability lead to better products. This specific role involves independently managing compliance audit processes, serving as a resource for internal and external audits, state licensing, and regulatory intelligence. You will lead investigations, contribute to metrics analysis, support inspection readiness, and mentor junior team members.

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

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