Data and Documentation Management Quality Associate

Baxter

  • Tijuana, B.C.
  • Permanente
  • Tiempo completo
  • Hace 8 días
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.About Us: Baxter's MissionAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.Your Role at BaxterResponsible for supporting the QMS and managing the development and revision of standard procedures and training materials for a global audience. Participate and drive department assessments and assure closure to items identified. Support and lead department improvement projects through successful implementation. Must have the ability to manage projects, work in a team setting and encourage teamwork and drive decisions. Provide guidance to internal/external customers on document and system related issues. Review and approve GMP/GLP Manufacturing and related documentation to support timely product and system release.Your Team at BaxterWithin 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
  • Highly proficient in project and configuration management.
  • Strong technical writing skills for creating and editing content, particularly to procedures and templates that support the global Quality Management System.
  • Leading document creation and initiation activities while maintaining effective communication and developing partnerships with customers globally.
  • Provide training to internal and external personnel on documentation/labeling/archive related processes and systems.
  • Perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Maintain expertise in quality systems and quality techniques.
  • Actively participate in process improvement and the implementation of new/enhanced processes.
  • Maintain a high level of expertise in current regulatory requirements and technical issues. Participate in QA/QC multi-site projects in the role of contributor, coordinator or leader.
  • Support internal and external audit activities.
What you'll bring
  • Proficient in the document change control process.
  • Skilled in Desktop publishing, Graphics/Illustrations software and document management (e.g. Word) software applications.
  • Data/Document configuration management proficiency.
  • Facilitating training.
  • Strong project management skills.
  • Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
  • Familiarity with interpreting regulations and quality systems.
  • Understand strategies and be able to develop new businesses process/tools.
  • Good interpersonal/communication/influencing/negation skills.
  • Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Knowledge of product/document configuration management.
  • Working knowledge of related business systems.
  • Working knowledge Quality Management Systems
Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

Baxter