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The position may be responsible for analytical testing, validation/verification/transfer of test methods, and qualification of laboratory equipment supporting parenteral products. The position will be located in the Round Lake, IL Stability Laboratories within Global Product Quality serving multiple global businesses and testing sites.

Essential Duties and Responsibilities:
Responsibilities include, but are not limited to, the following:
l Supervise critical chemical, physical, and particulate analyses on finished product stability samples.
Perform review of test data, which includes overall documentation practices. Perform review and other relevant roles in LIMS or other computerized systems.
l
l Mentor others within the team, provide training, and conduct supervisory activities.
Support key process improvement initiatives including owning, reviewing and approving change controls
l
Perform investigations into suspect data to identify laboratory causes and implement corrections, corrective actions and/or preventive actions (CAPA). Investigate deviations and write exception documents to address impact.
l
Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet customer expectations, project schedules and budget.
l
Participate in laboratory metrics to monitor, achieve, and improve KPI’s that support global stability governance.
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Use sophisticated laboratory instrumentation and computer systems to collect and record data. May
be required to be a system owner, administrator and/or conduct qualifications. Perform and approve
equipment maintenance and calibrations as required. Troubleshoot and resolve instrument
problems.
l
Maintain knowledge of quality systems including data integrity and ensure compliance with
company SOPs and specifications, FDA, cGxP, and QSR regulations. May own SOPs as subject
matter expert, as required. Maintain laboratory safety requirements and perform laboratory audits
as required. Audit SOPs and update, as required.
l
Participate in cross functional teams to bring new products to market, increase efficiency, solve
problems, generate cost savings, improve quality and provide sustaining product support. May
include test method or process improvements. Act as change owner.
l
Qualifications:
Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods
of analysis. Experience/knowledge with method development, validation and transfer.
l
l Possess good understanding of ICH, cGxP, and compendial guidelines (e.g. USP).
Knowledge and experience with HPLC/UPLC, GC, pH, UV, Empower, LIMS and other analytical
chemistry techniques, instruments, and software.
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Must demonstrate effectiveness in ability to train and develop self and others, leadership,
organization, teamwork/interpersonal skills, quality results orientation, and task completion.
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l Must be able to handle multiple tasks concurrently and in a timely fashion.
l Possess good presentation, writing and computer skills.
l Must communicate and collaborate effectively with managers, peers, and subordinates.
l Ability to interpret available lab data, draw conclusions, make recommendations, and lead resolution to technical challenges.
Education and/or Experience:
Bachelors degree in Chemistry or biological science with analytical chemistry laboratory coursework
and at least 5 years experience, or Masters Degree in Chemistry, or Biological Sciences with at
least 1-4 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.
                                                                                                                                                               
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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.