Quality Associate III, Sterility Assurance Round Lake, IL

Job description

Overview This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. Support for Parents Continuing Education/ Professional Development Employee Health & Well-Being Benefits Paid Time Off 2 Days a Year to Volunteer Success Profile What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit. Detail Oriented Continuous Learner Courageous Collaborative Critical Thinker Influential Quality Associate III, Sterility Assurance Apply Now 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. Summary: Sterility is critical to patient safety, and maintaining it requires expertise, vigilance, and a commitment to quality. As a Quality Associate III, Sterility Assurance at Baxter, you will support QC Sterility Assurance operations at Baxter's manufacturing facility in Round Lake, IL. In this role, you will provide technical and execution support for sterility assurance and contamination control programs that support sterile pharmaceutical manufacturing operations. You will be responsible for planning, executing, documenting, and evaluating technical studies, investigations, risk assessments, qualification activities, data trending, and continuous improvement initiatives related to aseptic processing, sterilization and decontamination, environmental monitoring, microbiological control, and contamination control. You will apply scientific, engineering, microbiological, and quality principles to evaluate process performance and contamination risk. You will support investigations of atypical conditions and adverse trends while developing technically sound conclusions and recommendations. Working cross-functionally with Sterility Assurance, Quality, Manufacturing, Microbiology, Validation, Engineering, and Maintenance teams, you will help execute and sustain site sterility assurance programs. This position is primarily an individual contributor role, providing independent technical execution while developing expertise as a Sterility Assurance subject matter expert. Essential Duties and Responsibilities: Sterility Assurance Study Execution : Plan, develop, execute, and document sterility assurance studies supporting aseptic processing, sterilization, decontamination, contamination control, qualification, process characterization, and continuous improvement activities. Develop protocols, sampling plans, acceptance criteria, data summaries, technical reports, and study conclusions. Sterilization & Decontamination : Execute and support technical activities associated with sterilization and decontamination systems, including cycle development and characterization, qualification/requalification, biological indicator studies, chemical indicators, process parameter evaluation, cycle performance assessment, and investigation of atypical qualification results. Aseptic Processing & Contamination Control : Support evaluation and improvement of aseptic processing and contamination control systems, including personnel and material flow, interventions, equipment and facility design, cleaning and decontamination practices, environmental monitoring, contamination pathways, and implementation of risk reduction measures. Investigations, Risk Assessment & CAPA : Lead or support sterility assurance and microbiology-related investigations, deviation assessments, cause evaluations, product/process impact assessments, and quality risk assessments. Evaluate process, equipment, microbiological, environmental, qualification, and historical data to identify potential causes, contributing factors, trends, and appropriate corrective or preventive actions. Environmental & Microbiological Data Analysis : Analyze and trend environmental monitoring, biological indicator, qualification, aseptic process simulation, sterilization/decontamination, and other sterility assurance data to identify adverse trends, recurring events, emerging contamination risks, and opportunities for improvement. Qualification & Validation Support : Develop and execute qualification protocols and technical assessments supporting sterile manufacturing equipment and processes. Evaluate study results, deviations, atypical findings, acceptance criteria failures, and qualification data to support scientifically justified conclusions and recommendations. CAPA & Remediation Execution : Support implementation of corrective and preventive actions and Sterility Assurance remediation initiatives. Execute assigned technical workstreams, studies, data reviews, effectiveness assessments, procedural improvements, and sustained state monitoring activities. Technical Documentation : Prepare clear, accurate, and scientifically defensible protocols, reports, investigations, risk assessments, technical assessments, procedures, data summaries, and other GMP documentation. Ensure conclusions are supported by objective evidence and appropriately communicate limitations or uncertainty. Cross-Functional Technical Support : Partner with Quality, Manufacturing, Microbiology, Validation, Engineering, Maintenance, and other functions to resolve sterility assurance issues and execute improvement activities. Communicate technical findings and recommendations to cross functional stakeholders and escalate significant technical or compliance concerns when appropriate Qualifications: Must not be allergic to Penicillin and Cephalosporin or their related products and minerals. Knowledge of aseptic processing, contamination control, sterilization/decontamination, environmental monitoring, microbiological control, and sterile process qualification. Working knowledge of applicable GMP requirements, regulatory expectations, and industry standards for sterile pharmaceutical manufacturing. Demonstrated ability to independently execute technical studies, protocols, investigations, data reviews, and risk assessments. Ability to evaluate scientific, microbiological, equipment, and process data and translate findings into technically supported conclusions and recommendations. Strong problem-solving, technical writing, and data analysis skills. Ability to manage multiple technical activities and priorities within a GMP manufacturing environment. Effective communication and collaboration skills with the ability to work across Quality, Manufacturing, Engineering, Validation, and Microbiology functions. Ability to recognize unexpected or potentially significant results and appropriately escalate technical or quality concerns. Ability to lift up to 50 pounds when required. Occasional off-shift and holiday work required. Education and/or Experience: Bachelor's degree in microbiology, biology, engineering, pharmaceutical sciences, or related scientific/technical discipline. 3-5 years of relevant experience in sterile pharmaceutical manufacturing, Quality, Validation, Microbiology, En