Analyst III, Quality Lab-Microbiology

Baxter • Hayward, CA

1d • $88,000 - $121,000

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees