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***Must not be allergic to penicillin or cephalosporin drugs.***
 

Summary

Performs environmental surface and air testing, critical system testing, sterility testing, pyrogen testing, solution and device bioburden testing and microbiological identifications in compliance with all standard operating procedures including GDP, GMP, GLP and safety procedures.

Essential Duties & Responsibilities

• Responsible for compiling monthly and quarterly trending reports, performing routine laboratory prep work, writing and performing microbiological investigations, writing exception reports and performing microbiological qualifications of equipment.
• Conduct critical biological, chemical and physical analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at the Round Lake manufacturing facility. 
• Work under minimum supervision.
• Serve as mentor to Quality Laboratory Associate (QLA) I positions. 
• Provide training and work direction for QLA I positions as required.
• Perform review of test data, which includes overall documentation practices. 
• Perform release functions in LIMS or other computerized systems.
• Use sophisticated laboratory instrumentation and computer systems to collect and record data.
• Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
• Perform laboratory and manufacturing audits as required.  Audit and update , as required, plant SOPs.
• Perform equipment maintenance and calibrations as required.

Qualifications

• Must have good oral and written communication skills, strong analytical skills and be detail oriented.
• Knowledge of current Good Manufacturing Practices is preferred.
• Advanced laboratory skills with basic knowledge of statistical method.
• Strong technical problem solving skills.
• Ability to handle multiple tasks concurrently, and in a timely fashion.
• Computer literate.
• Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.
• This is a second shift position
• Must not be allergic to penicillin or cephalosporin drugs.

Education

• Bachelor degree in Microbiology, Chemistry or biological science with 2 – 4 years experience.

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.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.