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Summary:

Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. 

Essential Duties and Responsibilities:

• Monitor product quality through the performance of required visual and functional testing. Maintain a working knowledge of statistically based Sampling Plans and their applications. 
• Promote process control through activities in support of equipment and process validations. These activities are primarily product checks that support or refute validation studies.
• Monitor processes through the implementation of World Class Manufacturing Strategies, including Statistical Process Control (SPC). Responsible for generating and interpreting SPC control charts.
• Ensure the accuracy of measuring and testing equipment through the performance of calibrations.  · Perform periodic audits of manufacturing practices and local procedures. · Procedural changes in response to these audits may be initiated and coordinated by the QA inspector.
• Support the corrective and preventive action program by assisting with expectation situations. 
• Responsible for gathering, analyzing, summarizing, and distributing process relevant data.
• Promote continuous improvement through participation (i.e. team leader / facilitator or major contributor) in Process Management Team program.
• Handle customer complaints in a timely manner. This includes sample analysis, batch record review, historical trend reviews, root cause identification, and official documentation of findings.
• Must be able to effectively communicate across all departments and levels of management. 

Qualifications:

• Knowledge of GMP documentation and FDA required.  · Demonstrated attention to details and accuracy required.  · Must have good communication skills. · General knowledge of quarantine and warehouse operation helpful. · May be required to work flexible hours and overtime on short notice. 

Education and/or Experience:

• Bachelors degree with 0-2 years related experience or Associates with 1-3 years related experience or High School diploma with 2-4 years related experience. · Experience in a pharmaceutical or Biotech industry helpful. · Must be familiar with cGMP and FDA requirements. · Knowledge of aseptic techniques may be required.

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.