Quality Associate III, Sterility Assurance

Baxter International; Round Lake (IL); On-site; USD 80,000 - 120,000; Full time

Job summary

Baxter is seeking a Quality Associate III, Sterility Assurance at its Round Lake, IL facility. You will provide technical execution and support for sterility assurance programs across aseptic processing, sterilization, and contamination control, partnering with Quality, Manufacturing, Microbiology, Validation, Engineering, and Maintenance.

The role emphasizes investigations, data analysis, risk assessment, and CAPA with opportunities to develop SME expertise in sterility assurance within a GMP

Qualifications

• 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, Engineering, Sterility Assurance, or a related technical discipline.
• Experience supporting aseptic processing, sterilization/decontamination, environmental monitoring, contamination control, or sterile process qualification preferred.

Responsibilities

• Plan, develop, execute, and document sterility assurance studies supporting aseptic processing, sterilization, decontamination, contamination control, qualification, process characterization, and continuous improvement activities.
• 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.
• 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.
• Lead or support sterility assurance and microbiology-related investigations, deviation assessments, cause evaluations, product/process impact assessments, and quality risk assessments.
• 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.
• Develop and execute qualification protocols and technical assessments supporting sterile manufacturing equipment and processes.
• Support implementation of corrective and preventive actions and Sterility Assurance remediation initiatives.
• Prepare clear, accurate, and scientifically defensible protocols, reports, investigations, risk assessments, technical assessments, procedures, data summaries, and other GMP documentation.
• Partner with Quality, Manufacturing, Microbiology, Validation, Engineering, Maintenance, and other functions to resolve sterility assurance issues and execute improvement activities.

Education

Bachelor's degree in microbiology, biology, engineering, pharmaceutical sciences, or related scientific/technical discipline

Job description

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 elevate 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 escalated 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, Engineering, Sterility Assurance, or a related technical discipline.
• Experience supporting aseptic processing, sterilization/decontamination, environmental monitoring, contamination control, or sterile process qualification preferred.

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 $80,000 - $120,00 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.

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. Benefits | Baxter

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.

25212 W Illinois Route 120 RL/Drug|Round Lake, IL 60073|United States of America