Associate I, Quality,

Baxter International Inc.; Marion (NC); On-site; USD 68,000 - 94,000; Full time

Benefits offered by this job

Medical, Dental and Vision coverage

Paid Time Off and Holidays

401K match

Employee Stock Purchase Program

Paid Parental Leave

Tuition Reimbursement

Job summary

Baxter International Inc. is seeking a Quality professional to provide oversight and regulatory/compliance support. The role focuses on risk assessment, process improvement, and ensuring adherence to cGMP and FDA guidelines.

You will lead daily quality operations, supervise staff, and contribute to writing and revising SOPs while supporting internal and external audits. Competitive benefits begin on day one, with opportunities for growth and impact.

Qualifications

• Bachelor's degree strongly preferred. Degree in engineering or science preferred.
• Knowledge of FDA Regulations, Good Laboratory Practices, and Good Manufacturing Practices as applicable.
• Strong interpersonal skills and excellent verbal and written communication.
• Ability to manage people, encourage teamwork and drive decisions.

Responsibilities

• Identify and assess regulatory and quality risks per agency rules and Baxter practices.
• Leads ongoing daily departmental operations.
• May supervise assigned personnel to achieve quality goals; interview/hire, evaluate, train and develop reports.
• Perform in-depth assessments by collecting and analyzing evidence on risks and magnitude.
• Determine logic, adequacy and effectiveness of processes and systems.
• Develop plans to correct identified risks and implement approved actions.
• Write, review, and revise SOPs to meet corporate and regulatory requirements.
• Support external audits and assist with audit reports.

Skills

Quality oversight

Regulatory knowledge

Team supervision

Process improvement

Attention to detail

Education

Bachelor's degree in engineering or science

Job description

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.

Your Role at Baxter

Position Summary

Responsible for providing Quality support and oversight via process/area project and process development.

Your Team

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.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What We Offer From Day One

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

What You'll Be Doing

• Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
• Leads ongoing, daily departmental operations.
• May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports
• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
• Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
• Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
• Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Support external assessments or audits. Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
• Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s) Other duties, tasks or projects as assigned. Sustain a clean and safe work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

What You'll Bring

• Bachelor's degree strongly preferred. Degree in engineering or science preferred.
• Must be at least 18 years of age and possess a High School Diploma or GED.
• Strong interpersonal skills and great attention to detail are necessary.
• 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.
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.

Other Duties As Assigned

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.

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 $68,000-$93,500 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 location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

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.

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.

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

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.