Quality Lab Associate II – Sterility Assurance

Job description

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 This is where your creativity addresses challenges The Quality Laboratory Associate II – Sterility Assurance is responsible for authoring, revising, and maintaining microbiology and sterility assurance GMP documentation, ensuring alignment with regulatory expectations, site practices, and global quality standards. This role supports contamination control, investigation readiness, inspection preparedness, and consistent laboratory execution through high‑quality, accurate, and compliant documentation. Your Team at Baxter Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. What we offer from Day One Medical, Dental and Vision coverage 160 hours of Paid Time Off and Paid Holidays 401K match Employee Stock Purchase Program Paid Parental Leave Tuition Reimbursement What you'll be doing Author, revise, and maintain microbiology and sterility assurance documentation, including: Standard Operating Procedures (SOPs), Work Instructions, Protocols and reports (EMPQ, validation, qualification), forms, templates, and controlled records. Evaluate existing documentation and determine appropriate revisions to ensure alignment with current processes, regulatory requirements, and quality system expectations. Interpret complex microbiology, contamination control, and laboratory practices and translate them into clear, accurate, compliant, and executable documentation. Collaborate with the following SME’s to assess documentation needs and recommend improvements that enhance compliance, efficiency, and laboratory execution: Bioburden, Environmental Monitoring, Identification, Lysate, Particulate Matter, Investigations, Sterility Assurance. Determine appropriate documentation strategies to support contamination control initiatives, inspection readiness, and operational consistency. Ensure documentation aligns with: cGMP, GDP, FDA, USP, ISO, and internal quality system requirements, site-specific contamination control strategies Review and approve document changes within assigned authority levels, ensuring accuracy, consistency, and regulatory compliance. Support change control activities by evaluating the impact of proposed changes and coordinating documentation updates related to: CAPAs, investigations, continuous improvement initiatives, process or facility changes. Prioritize documentation activities based on business needs, compliance risk, investigation outcomes, and site objectives. Participate in cross-functional project teams and provide recommendations that support laboratory improvements, simplification efforts, and deviation reduction initiatives. Conduct independent reviews of microbiology documentation and determine document readiness for implementation, audit support, and regulatory inspection. Identify documentation gaps, compliance risks, and process vulnerabilities and make recommendations to mitigate potential execution errors or deviations. Support audits and inspections by: preparing documentation packages, leading or supporting document walkthroughs, providing documentation expertise during regulatory interactions. Establish and maintain document version control, consistency standards, and archival compliance requirements. Make recommendations to simplify, standardize, and improve documentation systems and practices to enhance effectiveness and reduce rework. Exercise sound judgment in resolving documentation issues, prioritizing competing requests, and escalating compliance concerns as appropriate. Sustain a clean and safe work environment utilizing 6S principles. Learn, understand, and apply rigorous quality standards, SOPs, and Current Good Manufacturing Practices (cGMP). What you'll bring Bachelor’s degree in Microbiology, Biology, Chemistry, Technical Writing, or related scientific discipline required. 5 or more years’ experience in a regulated pharmaceutical, medical device, or biologics environment. Previous experience writing or managing microbiology, sterility assurance, or manufacturing quality documentation strongly preferred. Experience with change management and document control systems required. Working knowledge of GMP documentation principles, regulatory expectations, and quality system requirements. Understanding of microbiology, contamination control, and laboratory quality systems. Demonstrated ability to work independently and make informed decisions with minimal supervision. Ability to evaluate documentation risks, determine appropriate corrective actions, and recommend sustainable solutions. Professional judgment in managing controlled documentation, interpreting regulatory requirements,