Associate III, Quality

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Position Summary

Responsible for quality assurance review of investigations and corrective and preventative actions across a department or functional area. Responsibility includes ensuring timeliness of the

investigation and review process, root cause identification adequacy, compliance with good documentation practices, mitigation and containment strategies, and approval of appropriate

Effectiveness Plans for the actions identified, including effectiveness criteria and timeframe. A functional understanding of FDA, ISO and Baxter Quality systems is required.

Job Responsibilities

• Perform quality approver review of investigations providing guidance to investigators on root cause investigation adequacy and regulatory compliance.
• Promotes standardization of investigations within the department and appropriate use of investigative tools to determine root cause.
• Ensures adequate identification of corrective and preventative actions aimed at minimizing or eliminating nonconformance recurrence.
• Measures process performance metrics to drive investigation improvement and compliance.
• Works closely with investigators to facilitate timely closure of investigations and CAPA; responsible for meeting product release commitments.
• May interface directly with FDA and other external and internal inspectors to present investigations and associated corrective and preventative actions.
• Ensures adherence to all SOPs, policies and procedures, including any department specific requirements.
• Ensure investigations follow the CAPA procedure, including all investigation element requirements per local and corporate procedures.
• Learn, understand and apply rigorous quality standards and Current Good Manufacturing Practices (cGMP)
• Sustain a clean and safe work area using 6S principles.

Knowledge, Skill and Abilities

• Strong knowledge of applicable procedures, specifications, regulations and standards. Experience interpreting and complying with cGMP within a pharmaceutical manufacturing environment.
• Strong analytical and problem-solving skills with applied experience in root cause determination and utilization of root cause tools.
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Experience in performing or reviewing chemistry and / or microbiology nonconformance investigations is desirable.
• Understand verbal and written 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.

Education and Experience

• Requires a bachelor’s degree, from an accredited institution, preferably in a scientific or technical discipline.
• 4-8 years of experience in quality assurance role in a manufacturing environment in the pharmaceutical, biotechnology, medical device or comparable field preferred.
• Must be at least 18 years of age.

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $68,000 to $156,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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.