Quality Associate III,

Quality Associate III – QC Microbiology at Round Lake Drug Delivery At Baxter, we believe every person deserves a chance to live a healthy life. Our mission is to save and sustain lives through a culture of courage, trust, and collaboration. Responsibilities Support QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations. Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems. Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions. Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement corrective actions. Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations. Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness. Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools). Share knowledge and provide guidance to colleagues; contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries. Qualifications Bachelor’s degree in Microbiology, Biology, Chemistry, or a related field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master’s degree in a related field with 5+ years of relevant experience. Experience with microbiological testing and environmental monitoring in regulated settings. Familiarity with investigation processes (e.g., OOS, OOT) and structured problem‑solving approaches. Ability to develop and maintain GMP‑compliant documentation (e.g., SOPs, test methods, protocols). Knowledge of cGMP and regulatory expectations, including data integrity principles. Experience using laboratory systems (e.g., LIMS). Clear communication skills and the ability to present technical information understandably. Strong organizational skills and the ability to manage multiple responsibilities. Experience in sterile manufacturing or contamination control environments. Exposure to regulatory inspections or audits within a microbiology function. Experience supporting the implementation of new laboratory systems, tools, or process improvements. Interest in mentoring or sharing knowledge with team members. Familiarity with data analysis, trending tools, or digital laboratory solutions. The estimated base salary for this position is $96,000 - $132,000 annually. Individual pay may vary based on location, skills, experience, and other factors. This position may also be eligible for discretionary bonuses. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. Benefits Baxter offers comprehensive compensation and benefits packages. Health and well‑being benefits include medical and dental coverage starting on day one, life and disability insurance, and medical leave options. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) and a 401(k) plan with options for employee contributions and company matching. Additional benefits include flexible spending accounts, educational assistance programs, paid holidays, paid time off, parental leave, commuting benefits, employee assistance programs, and childcare benefits. 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. #J-18808-Ljbffr Baxter International Inc.