Quality Associate III, Sterility Assurance
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 that support sterile pharmaceutical manufacturing. It involves 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. The position applies scientific, engineering, microbiological, and quality principles to evaluate process performance and contamination risk. It supports investigations of atypical conditions and adverse trends and develops technically supported conclusions and recommendations. The role works cross-functionally with Sterility Assurance, Quality, Manufacturing, Microbiology, Validation, Engineering, and Maintenance teams to execute and sustain site programs. It is primarily an individual-contributor role requiring independent technical execution while developing expertise as a Sterility Assurance subject matter expert.
Requirements
- 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.
- 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, including 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 is required.
Nice To Haves
- Experience supporting aseptic processing, sterilization or 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 technical activities, including cycle development and characterization, qualification and requalification, biological indicator studies, chemical indicators, process parameter evaluation, cycle performance assessment, and investigation of atypical qualification results.
- Evaluate and improve 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 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 potential 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 to identify adverse trends, recurring events, emerging contamination risks, and improvement opportunities.
- 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, including assigned technical workstreams, studies, data reviews, effectiveness assessments, procedural improvements, and sustained-state monitoring.
- Prepare clear, accurate, scientifically defensible protocols, reports, investigations, risk assessments, technical assessments, procedures, data summaries, and other GMP documentation.
- Ensure conclusions are supported by objective evidence and communicate limitations or uncertainty appropriately.
- 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.
Benefits
- Medical and dental coverage starting on day one
- Basic life, accident, short-term disability, long-term disability, and business travel accident insurance
- 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
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays
- Paid time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare benefits
- May be eligible for discretionary bonuses
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
