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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.
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.
Perform microbial and particulate monitoring of clean rooms throughout the facility.
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.
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)
401(k) Retirement Savings Plan (RSP)
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, family and medical leaves of absence, and paid parental leave