Quality Associate I, Receiving & Inspection

This is where  your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

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 What you'll Be Doing 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. Will work in both Drug Delivery and Penicillin facilities as needed.

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. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $68,000 - $93,500 annually. The