THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

KNOWLEDGE, SKILLS, AND ABILITIES

• Computer literate/knowledge of Microsoft office applications (Word, Excel)
• Proficient in quality based computer systems such as LIMS, POMS, Endoscan-V software, Sampler Sight Pharma, AS400, and TrackWise
• Attention to detail and able to manage multiple tasks/priorities in a timely manner
• Proficient in the operation of laboratory instrumentation and equipment such as laminar flow hoods, micro-pipettors, pH meters, analytical balances, and instruments used to perform particulate matter and endotoxin testing
• Good documentation skills and knowledge of GDPs (Good Documentation Practices)
• Knowledge of aseptic sampling and testing techniques and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
• Must be able to communicate effectively with all levels of the organization
• Must be experienced in executing general microbiology procedures
• Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
• Ability to create an environment that values people, encourages trust, teamwork, and open communication through feedback and recognition

WHAT YOU’LL BE DOING

• Prepare samples and perform endotoxin testing on raw materials, solution, and water for bioburden
• Perform particulate matter testing on solution
• Perform daily pH meter, balance, and pipette verification
• Administrator for Honeywell Automated Temperature Monitoring System
• Perform peptidoglycan and gel clot testing as needed
• Review calibration and daily lab check reports and approve testing
• Generate monthly trend reports
• Perform limit recalculations for trending purposes
• Conduct investigations for out of limit results
• Sterility testing for LAL
• Document Subject Matter Expert
• Act as a liaison between Endotoxin lab and Operations for batch release test scheduling to ensure customer commitments are met
• Calibration of micro-pipettes, analytical balance, water bath, dry heat bath, depyrogenation ovens, light obscuration particle counters and spectrophotometer
• Responsible for daily lab upkeep including cleaning, glassware washing and depyrogenation, supply replenishment, syringe and endotoxin prep
• Sustain a clean and safe work environment utilizing 6S principles
• Operate laboratory instrumentation and equipment such as laminar flow hoods, micro-pipettors, pH meters, analytical balances, and instruments used to perform particulate matter and endotoxin testing
• Write, revise, and approve Standard Operating Procedures and review job-related technical documents
• Participate and/or support internal/external, and regulatory audits as needed
• Write exceptions, nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise
• Train others on systems, equipment, procedures as needed
• Serve as mentor to other Quality Laboratory positions
• Assist in the development and execution of department initiatives and KPI’s and effectively achieve team goals and expectations
• Assist in the development planning of direct reports
• Generate and execute protocols and method validations as needed
• Assist Investigators as needed with microbial out of limits investigations
• Act as a delegate for Quality Manager in their absence
• Ensure compliance with all applicable procedures/practices to include global and local SOP’s safety, USP, ISO, cGMP, and applicable regulations