Quality System Technician

Your Role at Baxter

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality System Technician, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it’s building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there’s a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you’ll be doing

• Responsible to observes, takes correctives actions on product quality, system adequacy, productivity and employee safety is maintained for the manufacturing operation. Manages exception situations and make decisions during production process. Monitors quality improvement, value improvement, statistical and protocol validation projects for the manufacturing operation. Monitors quality indicators reports to prepare the Quality Trend. Active participation in Quality Teams.
• Performs and manages assessments of process, systems, and products to ensure cGMP’s compliance.
• Review and approve Environmental Maintenance Report (EMR)
• Responsible to determines and measures quality and reliability of products.
• Understands product flow in order to determine product traceability and downstream effect on decisions.
• Fill out, reviews and maintains all reports as required (daily, weekly, monthly, annually) in compliance with cGMP’s, cGDP’s and other internal and external standards (e.g. Documentation Supplements, Product Retention Records, Quality Impact Statements, Printed material, Manufacturing Checker Charts, Batch Interruption Notification, Stability, Sterility, FOR & FOC ).
• Maintains update knowledge of all relevant SOP’s and specifications; submit changes to SOP’s and standards to keep quality of the area.
• Ability to solve daily quality and equipment issues to assure the most efficient, effective and safety product release.
• Capable to understand product flow in order to determine product traceability.
• Coordinates monitors and performs sampling handling process, and send them outside (other Baxter facilities) as required.
• Trains manufacturing and quality personnel, review the quality department training manuals.
• Teamwork oriented, have an active participation in Plant teams.
• Should be able to work on special projects as assigned.
• Manage audits and approves standard operating procedures as “SAR”.
• Coordinates, supports and schedules shift weekends and staffing based on available resources and activities.
• Willing to work extra hours, any shift and during weekends when required.
• Supports the manufacturing department in Product/Process validation.
• Follow up validation codes.
• Assists the supervisor when it’s required.
• Supports the manufacturing area when it’s necessary.

What you’ll bring

• Bachelor’s degree; two (2) to five (5) years of previous experience in Quality Area. Excellent communication skills. Basic knowledge on computer programs such as: Excel, Word, etc.e
• Ability to communicate, read, write, and understand English/Spanish languages.