Quality Associate III, Sterility Assurance

Baxter•Round Lake, IL

2d•Onsite

About The Position

The Quality Associate III, Sterility Assurance supports QC Sterility Assurance operations at Baxter’s manufacturing facility in Round Lake, Illinois. The role provides technical and execution support for sterility assurance and contamination control programs used in sterile pharmaceutical manufacturing. It plans, executes, documents, and evaluates technical studies, investigations, risk assessments, qualification activities, data trending, and continuous improvement initiatives involving aseptic processing, sterilization and decontamination, environmental monitoring, microbiological control, and contamination control. The associate applies scientific, engineering, microbiological, and quality principles to assess process performance and contamination risks, and supports investigations of atypical conditions and adverse trends. The role works cross-functionally with Sterility Assurance, Quality, Manufacturing, Microbiology, Validation, Engineering, and Maintenance. It is primarily an individual-contributor position, with independent technical execution and development toward serving as a Sterility Assurance subject matter expert. The position requires a bachelor’s degree in a relevant scientific or technical discipline and 3–5 years of related experience. The estimated base salary is $80,000–$120,000 annually, and the position may also be eligible for discretionary bonuses. Baxter describes benefits for eligible roles, including health and insurance coverage, retirement and financial programs, educational assistance, time off, and other support programs.

Requirements

Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.
Knowledge of aseptic processing, contamination control, sterilization and 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 and 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.
Bachelor’s degree in microbiology, biology, engineering, pharmaceutical sciences, or a related scientific or technical discipline.
3–5 years of relevant experience in sterile pharmaceutical manufacturing, Quality, Validation, Microbiology, Engineering, Sterility Assurance, or a related technical discipline.
Occasional off-shift and holiday work is required.

Nice To Haves

Experience supporting aseptic processing, sterilization and decontamination, environmental monitoring, contamination control, or sterile process qualification.

Responsibilities

Plan, develop, execute, and document sterility assurance studies supporting aseptic processing, sterilization, decontamination, contamination control, qualification, process characterization, and continuous improvement.
Develop study protocols, sampling plans, acceptance criteria, data summaries, technical reports, and conclusions.
Execute and support sterilization and decontamination activities, including cycle development and characterization, qualification and requalification, indicator studies, process parameter evaluation, performance assessment, and investigation of atypical 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, environmental monitoring, contamination pathways, and risk reduction measures.
Lead or support sterility assurance and microbiology-related investigations, deviation assessments, cause evaluations, product and process impact assessments, and quality risk assessments.
Evaluate process, equipment, microbiological, environmental, qualification, and historical data to identify causes, contributing factors, trends, and corrective or preventive actions.
Analyze and trend environmental monitoring, biological indicator, qualification, aseptic process simulation, sterilization and decontamination, and other sterility assurance data.
Develop and execute qualification protocols and technical assessments for sterile manufacturing equipment and processes; evaluate results, deviations, atypical findings, acceptance criteria failures, and qualification data.
Support corrective and preventive action implementation and Sterility Assurance remediation initiatives, including technical workstreams, studies, data reviews, effectiveness assessments, procedural improvements, and sustained-state monitoring.
Prepare scientifically defensible GMP protocols, reports, investigations, risk assessments, technical assessments, procedures, and data summaries; support conclusions with objective evidence and communicate limitations or uncertainty.
Partner with Quality, Manufacturing, Microbiology, Validation, Engineering, Maintenance, and other functions to resolve issues and execute improvement activities.
Communicate technical findings and recommendations to cross-functional stakeholders and escalate significant technical or compliance concerns when appropriate.

Benefits

Medical and dental coverage starting on day one for eligible roles.
Basic life, accident, short-term disability, long-term disability, and business travel accident insurance coverage.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching options.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence and paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program.
Childcare benefits.
Potential eligibility for discretionary bonuses.