Quality Associate II, Training & Document Control

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!

This position is responsible for Document Control and Training Requirements. Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.

This position manages and maintains the day-to-day document change control process for processes related information within their department. The position also has responsibility to work closely with various managers at the facility to monitor, manage and maintain a central computerized training database of all employees at the facility.

Your Team

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.

What You'll Be Doing

Documentation:

• Ensures efficient processing of document and change management systems for the Quality Management System.

• Supervise the functional activities and employees associated with the creation, revision, issuance, review and storage of controlled quality records in compliance with GDP's. Ensure documents, forms, and records are accurate and complete.

• Ensures that records of changes to documents are maintained in accordance with regulatory requirements.

• Ensures documents of external origin (e.g., Regulations and Standards) are identified and evaluated for impact to the organization.

• Provide training, guidance and coaching in the areas of responsibility for direct reports, internal and external customers.

• Maintain Quality Metrics for document control, activities for Management Review and makes recommendations for improvement.

Training:

• Manages and monitors training completion via BaxU.

• Works with Managers and/or Lead Trainers to ensure training plans are developed for every job description and updated as necessary.

• Works with Human Resources to ensure Job Descriptions are written and updated as necessary.

• Works with other Baxter facility Learning Professionals as needed to ensure training is being managed in a uniform manner.

• Manage and communicate training metrics.

• Work with managers to organize/schedule training events as needed.

• Works with managers and external vendors to obtain Grant funding for training.

• Supports internal and external audits as needed.

What You'll Bring

• BS in business, science, or engineering is required.

• 3+ years’ experience in Quality with a medical device/pharma or other regulated industry.

• Experience in development and maintenance of a training documentation database.

• Working knowledge of other medical device regulatory requirements (US, Canada and Europe) is highly desirable.

• Excellent organizational, presentation, and verbal/written communication skills.

• Attention to detail.

• Ability to multi-task and work well u