Sterility Assurance Lead - Day shift (Monday to Friday 8:00-17:30)

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 Team at Baxter Within Quality, every role matters. Baxter ships products worldwide to patients in need. You may build new processes or solve unique production challenges. People in Quality have the trust and chance to bring creativity. No matter your specific role, your work will impact part 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. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to develop top-of-the-line products. We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps compose a better product for our customers. What you'll be doing Ensure compliance of CIVA’s Sterility Assurance program with regulatory and Baxter Corporate requirements. Direct CIVA’s Environmental Monitoring program and maintain alignment with applicable standards. Represent Sterility Assurance at various forums and communities of practice. Investigate and detail all Sterility Assurance related exceptions. Lead cross-functional teams in performing Environmental Performance Qualifications and Real Time Risk Assessments. Foster continual advancement of the Environmental Monitoring program. Update and maintain the Microbial Control Scheme and Plan. Ensure local SOPs are current and aligned with corporate and regulatory standards. What you'll bring Bachelor of Science in Pharmacy, Microbiology, Chemistry, or Biology. 3-5 years of relevant experience in a GMP regulated industry. Strong understanding of aseptic technique and GMP knowledge. Excellent problem-solving, critical thinking, and analytical skills. Ability to prioritize multiple tasks and work autonomously. Technical expertise in cleanrooms and aseptic processing is preferred. Experience leading teams and providing mentorship is preferred. We understand that 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 salary range for this position is $86,400 - $129,600 annually, which reflects base salary as well as estimated target payout under the Management Incentive Compensation Plan. Individual pay will be determined based upon skills, expertise and experience, and the incentive, which is contingent upon company and individual performance outcomes. 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. This posting is for a current existing vacancy within our organization. We are actively seeking qualified candidates to fill this open position. If you are interviewed for this position, we will advise you within 45 days of the interview as to whether or not you were successful in obtaining the position. Information submitted as part of the job application process will be kept on file for 3 years from the date of submission in accordance with legislative requirements. As part of our recruitment process, Baxter Corporation may use AI tools to assist screening candidates and assist in evaluating candidate qualifications. All final hiring decisions are made by the hiring manager and recruitment team 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. 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 .