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Summary:

Quality Associate performs daily quality review of raw material documentation to ensure that materials being received are produced in accordance to Company methodology, procedures, and standards. Quality Associate completes Change Control, Supplier Quality, and Nonconformance and Corrective Action Preventive Action (CAPA) quality records related to Receiving & Inspection. Quality Associate is SME for Receiving & Inspection procedures and manages projects.

***  The candidate must not be allergic to Penicillin or Cephalosporin drugs ***

Essential Responsibilities:

• Reviews and approves documentation for API (Active Pharmaceutical Ingredients), Excipients, Chemicals, Laminated Rollstock, Printed Direction Inserts, Labels, and Cartons.
• Provides Receiving and Inspection review support for materials purchased by Takeda.
• Manages raw material tracking log and scheduling work for R&I technicians.
• Manages RLDD Stability schedule and sends out Stability notices.
• Strong computer/software literacy, preferred experience with material inventory management systems.
• Creates reassay and expiration report on a monthly basis.
• Completes GME and Labvantage setups for materials.
• Supplier Quality (SQ) responsibilities to include SCAR (Supplier Corrective Action Request) writing and review; Reduced testing of materials - new and periodic review; SQ approval of raw material part records; and Risk Action and Mitigation (RAM) review for Round Lake Drug Delivery.
• Owns and manages Change Control records.
• Performs investigations for R&I nonconformances and owns R&I related CAPAs.
• Performs R&I procedure and training code revisions in document system.
• Completes Certification of Documentation Review (CDR) process for raw materials to implement them in the plant systems.
• Validation and testing of computerized systems, to include writing and executing a protocol.
• Submit and manage purchase orders in Coupa system.
• Manages quotes and sends samples to external testing labs.
• Complete and manage R&I Preventive Maintenance (PM) records in the Maximo system.
• Attends various Tier and Cross-Functional meetings as the R&I representative.
• Secondary responsibilities to support production, as needed.
  • Releases materials for production after quality inspections and/or tests are completed and acceptable.
  • Performs proofreading and laminated rollstock thickness testing. Monitors and verifies quality in accordance with statistical processes and other control procedures.
  • Uses small hand tools and various measuring and testing devices in performing quality tests.

• Will work in both Drug Delivery and Penicillin facilities as needed. 

Job Requirements:

***  The candidate must not be allergic to Penicillin or Cephalosporin drugs ***

• Minimum Associates Degree and one to three years of relevant experience required OR Bachelor’s degree and experience with a medical device/pharma or other similarly regulated industry preferred.  
• 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. 
• Complete understanding of cGMPs and GDP procedures.
• 20/30 vision in at least one eye with or without corrective lenses.
• The candidate must be able to work flexible hours in a dynamic environment with minimal direct supervision.

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.