Quality Associate III
About The Position
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter As a Quality Associate III – QC Microbiology, you will support microbiological quality at Round Lake Drug Delivery through technical expertise, collaboration, and continuous improvement. In this role, you will help ensure reliable testing, effective environmental monitoring, and strong contamination control practices. You will contribute to maintaining inspection readiness, addressing quality risks, and enhancing laboratory processes and systems.
Requirements
- Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific 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, particularly in regulated settings.
- Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches.
- Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols).
- Working knowledge of cGMP and regulatory expectations, including data integrity principles.
- Experience using laboratory systems (e.g., LIMS or similar tools).
- Clear communication skills with the ability to present technical information in an understandable way.
- Strong organizational skills and the ability to manage multiple responsibilities effectively.
Nice To Haves
- Experience in sterile manufacturing or contamination control environments.
- Exposure to regulatory inspections or audits within a microbiology function.
- Experience supporting 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.
Responsibilities
- Support and guide 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, including qualifications, method transfers, and change assessments.
- 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 effective 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) to strengthen efficiency and data integrity.
- Share knowledge and provide guidance to colleagues; contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries.
Benefits
- medical and dental coverage that start on day one
- insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan (RSP), with options for 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 (EAP)
- childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
