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Summary

Responsible for performing a wide variety of assignments in label copy control, sample management, documentation review, and other quality department functions.

Essential Duties and Responsibilities

This is a 2nd Shift Tuesday through Saturday position.

• Responsible for performing a wide variety of assignments in label copy control, sample management, documentation review, and other quality department functions.
• May make detailed observations, analyze data, and interpret results.
• Will maintain department equipment and inventory levels for controlled materials.
• Will interact with manufacturing and supervision on a daily basis to address quality process or batch related concerns.
• Performs process compliance audits of all manufacturing areas to ensure quality of product/process is achieved.
• Will perform troubleshooting, work independently, and make decisions based on general guidance and existing procedural requirements. 
• Will work in both Drug Delivery and Penicillin facilities as needed. 
• Regular overtime will be required to meet the production schedule.
• Performs in process and/or final review of batch and/or critical systems documentation and determines acceptability by using standard operating procedures.  Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
• Responsible for batch and/or critical systems review.  Achieves and maintains batch or systems release qualification within assigned production cell.
• Reviews documentation such as protocols, CWRs, qualifications, etc as assigned. 
• Enters data into the Batch Release System.  Generates reports from Trackwise 8.
• Performs product functional testing in support of equipment validations.

***  The candidate must not be allergic to penicillin or cephalosporin drugs ***

Qualifications

• Good writing and verbal communication skills, and problem solving skills are required.  
• Ability to work in a team environment and make independent decisions based on procedural and regulatory requirements 
• It is desirable for the candidate to have experience with the requirements of current Good Manufacturing & Documentation Practices in pharma manufacturing facilities.  
• The candidate must be able to work flexible hours in a dynamic environment with minimal direct supervision.

Education/Experience

• Associate’s Degree in related discipline or plus 0-3 years related experience. 
• Basic science, math, and computer skills (including Microsoft Word and Excel) are 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.