This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Position Summary

The role of the Quality Laboratory Associate III (QLA III) – Sterility Assurance is primarily responsible for executing routine activities and continuous improvement projects which promote contamination control of cleanrooms and manufacturing processes. This position may be an individual contributor role or may have 1-4 direct reports.

Job Responsibilities

• Lead continuous improvement projects to implement best practices as it relates to contamination control design and processes throughout the manufacturing facility.
• Understands and assures conformance to regulations applicable to sterility assurance. Interfaces with regulators during inspections as Subject Matter Expert (SME)
• Through continuous improvement efforts, work to streamline and improve cleaning procedures across multiple operating lines and areas.
• Write, review, and/or approve environmental cleaning protocols to support cleaning practices.
• Define, oversee, and improve training program(s) for cleanroom behavior and contamination control practices.
• Lead classroom-based training for new employees and continuous education classes for established employees of various backgrounds
• Responsible for the microbiological/sterility assurance risk assessment of changes to existing cleanroom practices
• Support ongoing projects throughout the facility by completion of environmental FMEAs, assessing potential impact of proposed changes, contributing to the design of projects, and performing risk assessments.
• Coordinate responses to environmental and process conditions detected during Real Time Risk Assessments (RTRA)
• Collaborate with microbial investigators and manufacturing compliance teams to determine potential CAPA items in response to microbial out of limits.
• Establish appropriate response plans to environmental events in cleanrooms.
• Author and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews.
• Performs regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement.
• Work collaboratively with regional sterility assurance experts to achieve company objectives and ensure policy alignment across site.
• Lead and participate in the investigation of microbiological events and cleaning deviations through nonconformance's in TrackWise.
• Sustain a clean and safe work area using 6S principles.
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Knowledge, Skill and Abilities

• Knowledge of standard microbiological procedures (environmental monitoring, bioburden, bacterial endotoxin testing)
• Knowledge of cGMP, GDP, GLP, Annex I, ISO 14644-1 standards
• Extensive knowledge in aseptic technique, cleanroom behavior and practice, cleaning methodologies, and risk assessments
• Strong communication and project management skills
• Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (DIMAIC, Ishikawa Diagram)
• Must have strong technical writing skills and ability to put complex thoughts and issues into writing in such a manner to be understood by the reader.
• Must be able to interact with, and influence others at various levels in multiple departments.
• Must be comfortable interacting with FDA or similar regulatory agencies.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.

Required Education and Experience

• Bachelor’s degree in Microbiology, Biology, or related science. Microbiology degree and related laboratory experience preferred.
• 7-10 years of experience in Pharmaceutical/Medical Device Industry, with 5+ years of experience in sterility assurance
• Must be at least 18 years of age.

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 our employees, and we strive to be more transparent with our pay practices.To that end, this position has a salary range of $60,000 to $132, and also includes an annual incentive bonus. The above range represents the expected salary range for this position.The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

Other Duties as Assigned

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.