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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. 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.
Job Responsibility
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
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
Weekend work may be required as needed to meet production timeline schedules
What we offer
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service