Analyst III, Quality Lab-Microbiology

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

This position is responsible for conducting microbiological in support of manufacturing, raw materials, environmental systems, validations, projects, and shelf-life studies. Additional secondary functions include authoring procedural updates, performing trending, and assisting in special projects related to improving lab processes or maintaining regulatory compliancy.

What You'll Be Doing

• Conduct Microbiological analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility. 
• Testing as required supporting Endotoxin testing, Bioburden analysis, microbial identifications, biological indicators, growth promotion, water.  Will be required to read microbial plates and interpret test results.
• Perform microbial and particulate monitoring of clean rooms throughout the facility. May be responsible for overseeing daily workflow of assigned area.
• Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in cleanrooms.
• Perform equipment maintenance and calibrations as required.
• Maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.
• Write and execute validations for manufacturing processes and laboratory instruments and methods.
• Work on special projects / protocol testing that involves new methods and instrumentation. Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Investigate deviations and write nonconformance documents
• Lead and/or actively contribute to a team setting within the laboratory to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Responsible for the identification and communication of adverse trends in routine microbiological monitoring.
• Consult on quality and microbiological issues, support problem solving and resolution, and provide quality management advice and counsel to customers for related laboratory testing needs.
• Support and lead continuous improvement projects in the QC Laboratories such as 5S, Kaizen, and VIP projects.
• Perform equipment maintenance and calibrations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

What You'll Bring

• B.S. degree in Microbiology, Biology, or related science experience; with minimum of 5 years’ experience, or Master’s Degree in Chemistry or biological science with 1-4 years’ experience.
• Knowledge of microbiology and environmental monitoring (Endotoxin, Bioburden, and EM monitoring test)
• Demonstrates some knowledge of assays/equipment in functional area. Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
• Proficient use of laboratory equipment and tools. Must be detail-oriented, conscientious, and responsible. Must have effective verbal and written communication skills. Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs.
• Must be able to learn new computer systems and programs in a timely manner.
• Strong leadership, organization and time management skills.
• Attention to detail and ability to prioritize multiple tasks in a timely manner.
• Effective organizational skills and ability to plan and suggest resolutions to technical problems.
• Strong data analysis and report writing skills.
• Weekend work may be required as needed to meet production timeline schedules.

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 $88,000 - $121,000 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 (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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