Risk Management Associate I

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.

Your role at Baxter

The Technical Services Associate I (Risk Management) is responsible for risk management activities associated with non-conformances, complaints, equipment validation, qualification and change control activities at the BPS site. This position interacts with clients, regulatory agencies and cross-functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely approval of all associated documents. This position reports to the Technical Services Validation Sr. Manager.

What you'll be doing

• Provide guidance and technical expertise of regulatory and Baxter requirements in Risk Management strategies and processes.
• Assess risk associated with non-conformances complaints, audits, change control etc. and update the site process FMEA with new risks as needed.
• Approve risk forms submitted with newly identified risk submitted via non-conformance investigations, complaints, audits, change control etc.
• Author and/or approve applicable risk assessment documents for equipment and manufacturing process related changes.
• Author and/or approve applicable deviation reports for product and process related deviations.
• Help lead Risk Management activities for sustaining Engineering/Manufacturing projects
• Provide SME input to risk remediation activities.
• Support risk assessment of new processes to be validated.
• Uses statistical tools to analyze data.
• Performs annual reviews of all process FMEAs.
• Participates in regulatory inspections.

What you'll bring

• Bachelor's degree required, preferably in a science or engineering related field
• Pharmaceutical industry experience in parenteral manufacturing a plus
• American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification a plus.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements

• Must be able to wear appropriate personal protective equipment.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours but may involve walking or standing for periods of time.
• Must be able to gown for Grade C area

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 $52,800 - $132,000 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. 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.

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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.

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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.

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