Quality Associate I — Quality Compliance
Baxter International Inc.
Summary
As a Quality Systems & Compliance Associate, you will provide flexible support across Quality Systems, Compliance, Investigations, and related quality programs. Rather than focusing on a single specialty area, you will gain exposure to a variety of quality processes that are essential to maintaining regulatory compliance and operational excellence.
Job description
Your Role at Baxter
As a Quality Systems & Compliance Associate, you will provide flexible support across Quality Systems, Compliance, Investigations, and related quality programs. Rather than focusing on a single specialty area, you will gain exposure to a variety of quality processes that are essential to maintaining regulatory compliance and operational excellence.
In this developmental role, you will support quality records, documentation, investigations, audits, reporting, training, and improvement initiatives while learning how quality systems work together to protect patients, products, and business performance. Success will be measured through accuracy, attention to detail, effective collaboration, and your ability to contribute to quality processes that support Baxter's commitment to excellence.
What You'll Be Doing
- Support Quality Management System (QMS) processes by maintaining records, tracking activities, and assisting with change controls, CAPAs, complaints, nonconformances, audits, and other quality programs.
- Enter, update, review, and manage information within electronic quality systems, ensuring records remain accurate, complete, timely, and inspection ready.
- Gather documentation, training records, manufacturing records, and other objective evidence to support investigations, audits, compliance activities, and quality decisions.
- Track action items, due dates, training completions, and record status while proactively communicating potential delays or risks.
- Compile, verify, and organize quality data used for dashboards, management reviews, trend reports, inspections, and continuous improvement initiatives.
- Support internal, customer, corporate, and regulatory audits by coordinating documentation, preparing evidence packages, and assisting with inspection readiness activities.
- Contribute to process improvements, documentation updates, training coordination, and cross-functional projects that strengthen quality system effectiveness.
What You'll Bring
Required Qualifications
- Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, Business, or a related field preferred; Associate degree with relevant experience or an equivalent combination of education and regulated-industry experience may be considered.
- 0-2 years of experience in Quality, Compliance, pharmaceutical manufacturing, medical device manufacturing, laboratory operations, engineering, document control, training, or another regulated environment.
- Strong organizational skills with exceptional attention to detail and commitment to accurate documentation.
- Ability to manage multiple priorities, follow established procedures, meet deadlines, and escalate concerns when appropriate.
- Strong written and verbal communication skills with the ability to collaborate effectively across teams and functions.
- Proficiency in Microsoft Office applications including Excel, Word, PowerPoint, and Outlook.
- Willingness and ability to learn new quality processes, systems, and regulatory requirements.
Preferred Qualifications
- Foundational knowledge of cGMP regulations, Good Documentation Practices (GDP), quality systems, or data integrity principles.
- Experience supporting document control, training administration, investigations, audits, compliance activities, or quality reporting.
- Exposure to regulated manufacturing environments such as pharmaceutical, biotechnology, medical device, food, or related industries.
- Familiarity with electronic Quality Management Systems (eQMS) such as TrackWise or similar platforms.
- Experience supporting continuous improvement projects, process mapping activities, or quality metrics reporting.
Requirements
- Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, Business, or related field preferred; Associate degree with relevant experience or equivalent combination may be considered
- 0-2 years of experience in Quality, Compliance, pharmaceutical manufacturing, medical device manufacturing, laboratory operations, engineering, document control, training, or another regulated environment
- Strong organizational skills with exceptional attention to detail and commitment to accurate documentation
- Ability to manage multiple priorities, follow established procedures, meet deadlines, and escalate concerns when appropriate
- Strong written and verbal communication skills with the ability to collaborate effectively across teams and functions
- Proficiency in Microsoft Office applications including Excel, Word, PowerPoint, and Outlook
- Willingness and ability to learn new quality processes, systems, and regulatory requirements
- Foundational knowledge of cGMP regulations, Good Documentation Practices (GDP), quality systems, or data integrity principles
- Experience supporting document control, training administration, investigations, audits, compliance activities, or quality reporting
- Exposure to regulated manufacturing environments such as pharmaceutical, biotechnology, medical device, food, or related industries
- Familiarity with electronic Quality Management Systems (eQMS) such as TrackWise or similar platforms
- Experience supporting continuous improvement projects, process mapping activities, or quality metrics reporting
- Applicants must be authorized to work for any employer in the U.S.
Benefits
- Medical & Dental Coverage
- Life Insurance
- Accident Insurance
- Short-Term Disability
- Long-Term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family & Medical Leave
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
- Discretionary Bonuses
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.