Quality Associate III - Analytical Laboratory

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

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 Associate, 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.
 

As a Quality Associate you will handle multiple analytical laboratory compliance projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. You should bring a functional understanding of FDA, ISO, EMA, and Global Regulators. This position will require the ability to assess and analyze standardized analytical methods and laboratory practice operating procedures.
 

What you'll be doing

• Lead ongoing global compliance activities for areas of direct responsibility and assist other quality areas in the successful performance of these activities
• Manage activities to meet quality goals in an efficient, accurate and timely manner
• Collaborate within GMP analytical laboratory across multiple locations globally.
• Assist in laboratory investigations at commercial sites and method troubleshooting
• Assess the laboratory practices and performance to identify potential risks out of regulatory requirements
• Partner in performing method transfers and validations
• Carry out synthesis and process monitoring in corporation with collaborators
• Observe and learn how the various operating areas interact and impact upon each other during the daily operations
• Record, interpret, and report lessons learned and deploy globally for harmonization
• Initiate and manage analytical laboratory practices global procedures assessment to identify gaps with regulations and promote harmonization
• Ensure business needs and timelines of the department are met or exceeded globally
• Write, review, analyze and revise written procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Partner with facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations<