Quality Control, Mgr

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.  Join a team where your impact matters! #ThisIsWhere Your role at Baxter The Quality Control Manager is responsible for providing strategic, technical, operational, and people leadership for the site’s Microbiology and Chemistry Laboratories. This role ensures compliant, timely, and scientifically sound execution of all laboratory activities supporting product quality, patient safety, regulatory compliance, batch disposition, and uninterrupted supply. The position oversees laboratory operations, environmental monitoring, analytical testing, contamination control programs, microbiological and chemical investigations, data integrity, inspection readiness, laboratory performance, talent development, and continuous improvement initiatives. The role serves as the primary quality laboratory subject matter expert and collaborates closely with Quality Assurance, Manufacturing, Engineering, Validation, Technical Services, Regulatory Affairs, Supply Chain, and Global Quality to proactively identify and mitigate quality and compliance risks.

Lead daily operations of the Microbiology and Chemistry Laboratories, ensuring timely execution, review, and approval of testing activities. Ensure laboratory testing supports product disposition, batch release, manufacturing operations, regulatory commitments, and supply continuity. Manage laboratory resources, staffing, workload prioritization, capacity planning, and performance objectives. Ensure all testing is performed in accordance with approved methods, specifications, procedures, sampling plans, regulatory filings, and cGMP requirements. Maintain laboratories in a continuous state of inspection readiness for regulatory inspections, customer audits, internal audits, and corporate assessments. Ensure laboratory documentation, calculations, records, electronic data, and audit trails comply with data integrity requirements. Provide technical leadership for microbiological and analytical quality systems, laboratory controls, instrumentation, contamination control strategies, sterility assurance programs, environmental monitoring, utility monitoring, and analytical methodologies. Support analytical method validation, verification, transfer, implementation, and lifecycle management. Oversee qualification, calibration, maintenance, troubleshooting, and lifecycle management of laboratory equipment and computerized systems. Ensure laboratory systems, chromatography platforms, electronic laboratory records, and data management processes remain compliant and effective Investigations & Risk Management Lead microbiological and analytical investigations related to OOS, OOT, deviations, contamination events, environmental monitoring excursions, sterility failures, utility excursions, equipment failures, and data integrity concerns. Drive root cause analysis, quality risk assessments, CAPA development, effectiveness verification, and continuous risk mitigation activities. Ensure timely escalation and management of risks that may impact product quality, patient safety, regulatory compliance, or supply continuity. Support quality risk assessments for manufacturing processes, facilities, equipment, utilities, product