Analyst II QC Lab

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 Performs advanced quality control testing and laboratory support activities to ensure product quality and compliance with regulatory requirements. Executes complex microbiological or chemical; supports investigations, method qualifications and validations, equipment calibration activities, data review, and laboratory continuous improvement initiatives. Provides technical guidance to QC Analyst I personnel and helps maintain inspection readiness in accordance with cGMP, GLP, SOP, and data integrity requirements. Supports laboratory investigations, NCR/CAPA activities, sample shipments to third-party laboratories, and coordination with external service providers. What You'll Be Doing Perform advanced microbiological testing using approved methods and procedures. Execute and review environmental monitoring, water testing, bioburden, endotoxin, and other microbiological analyses. Support environmental monitoring investigations and assessment of microbiological excursions. Trend microbiology data and identify adverse trends, recurring issues, and opportunities for improvement. Support microbiological method qualifications, verifications, validations, and transfers. Perform and support equipment calibration, maintenance, qualification, and troubleshooting activities. Review laboratory data, test records, and reports for accuracy, completeness, and compliance. Assist with laboratory investigations, deviations, NCRs, CAPAs, and change control activities. Support internal audits, customer audits, and regulatory inspections. Mentor and train Analyst I personnel on laboratory procedures, testing techniques, and documentation practices. Support procurement of laboratory supplies, media, reagents, and consumables required for testing activities. Coordinate with external vendors for equipment calibration, troubleshooting, maintenance, and contract testing services. Prepare, package, and ship samples to third-party laboratories while maintaining proper documentation and chain of custody. Ensure compliance with SOPs, cGMP, GLP, safety requirements, and data integrity principles. Perform advanced chemical and physical testing of raw materials, in-process samples, and finished products using established analytical methods. Complete complex analytical techniques and provide technical support for routine laboratory operations. Troubleshoot analytical methods, instrumentation, and laboratory processes to ensure reliable and accurate results. Support Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, nonconformance, and laboratory investigations. Assist with analytical method qualifications, validations, verifications, and transfers. Perform and support equipment calibration, maintenance, qualification, and troubleshooting activities. Review analytical data, calculations, chromatograms, and laboratory documentation for accuracy and compliance. Support laboratory projects, process improvements, and continuous improvement initiatives. Provide technical guidance and mentorship to Analyst I personnel. Support procurement of laboratory supplies, standards, reagents, and consumables required for testing activities. Coordinate with external vendors for equipment calibration, troubleshooting, maintenance, and contract testing services. Prepare, package, and ship samples to third-party laboratories while maintaining proper documentation and chain of custody. Support NCRs, CAPAs, and quality system activities related to laboratory operations. Ensure compliance with SOPs, cGMP, safety requirements, and data integrity principles. What You'll Bring 2-5 years of experience in a regulated laboratory environment. Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific field. Working knowledge of cGMP, GLP, data integrity, and Good Documentation Practices (GDP). Experience supporting investigations, method validations, and equipment qualification activities preferred. Strong analytical, problem-solving, organizational, and communication skills. Ability to review technical data, identify trends, and work independently with minimal supervision. Proficiency with laboratory software, LIMS, and Microsoft Office applications. 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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $72,000 - $99,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. 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. US Benefits at Baxter (exce