Quality Associate I

This is whereyour 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.

Your Role at Baxter

This is where your creativity addresses challenges!

This position is responsible for areas of the Quality System. Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.

This position manages and maintains the day-to-day change control process, risk analysis reviews for processes related information within their assigned site. The position also has responsibility to work closely with various managers at the facility to monitor, manage and maintain a central computerized change control database of all employees at the facility.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

What You'll Be Doing

• Ensures efficient processing of change management for the Quality Management System in Trackwise.

• Maintain Quality Metrics for change control timeliness and makes recommendations for improvement.

• Leads and maintains all Management Review activities for the site.

• Ensures documents of external origin (e.g., Regulations and Standards) are identified and evaluated for impact to the organization.

• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.

• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items.

• Identifies areas for process/quality improvements and supports those efforts.

• Risk Management - Writes and publishes risk analysis for products for both the site level and to the corporate team for feedback.

• Follows Good Documentation Practices (GDP) and ensures compliant documentation related to area of responsibility.

• Conducts approvals of change requests, supplier change requests, validations. and coordination for escalation of change requests for deviations.

What You'll Bring

• Associate Degree in business/scientific discipline required.

• Bachelor's Degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.

• 1-3+ years of relevant experience.

• Strong interpersonal skills and great attention to detail are necessary.

• Must be able to handle multiple projects concurrently.

• Have strong knowledge of FDA Regulations, Application of Good laboratory Practices, and Application of Good Manufacturing Practices.

• Must be a strong team player with good problem solving and good verbal and written communication skills.

• Must have the ability to manage people, encourage teamwork and drive decisions.

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.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $64,000 - $85,000 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, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

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.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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