Quality Associate I, Receiving & Inspection,

About the role

At Baxter, our guiding principle is that every person deserves a chance to live a healthy life. As a Quality Associate, you will perform daily quality review of raw material documentation to ensure materials received meet Company methodology, procedures, and standards. You will complete Change Control, Supplier Quality, and Nonconformance/Corrective and Preventive Action (CAPA) records related to Receiving & Inspection, serve as the SME for Receiving & Inspection procedures, and manage projects. The candidate must not be allergic to Penicillin or Cephalosporin drugs.

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.
• Creates reassay and expiration report on a monthly basis.
• Completes GME and Labvantage setups for materials.
• Performs Supplier Quality (SQ) responsibilities including SCAR writing and review; reduced testing of materials; 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, including writing and executing a protocol.
• Submits and manages purchase orders in Coupa system.
• Manages quotes and sends samples to external testing labs.
• Completes and manages R&I Preventive Maintenance (PM) records in the Maximo system.
• Attends various Tier and Cross-Functional meetings as the R&I representative.
• Provides secondary support to production as needed.
• Works in both Drug Delivery and Penicillin facilities as needed.

Requirements

• Associate 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.
• Ability to work flexible hours in a dynamic environment with minimal direct supervision.

Pay

The estimated base salary for this position is $68,000 – $93,500 annually. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Medical and dental coverage starting on day one.
• Basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP) with company stock discount.
• 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching.
• Flexible Spending Accounts and educational assistance programs.
• Paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits.