Baxter Quality Documentation Anlayst in United States
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
The role of the Quality Documentation Analyst is to ensure, as per local procedure, the management and the maintenance of:
internal document change requests.
external documents (Corporate and EMEA documents implementation, Iso, PL card, other Baxter documents,…) implementation
Essential Duties and Responsibilities
Assure the creation, review, on-time publication and the obsoletion of local documents in TCU
Maintain local databases
Assure the archiving of local documents as per CQP (Corporate Quality Procedure) and regulation requirements
Provide KPI and indicators when needed
Assure training on internal documents process
Be the key contact for SME for TCU issues
Ensure document updates with project leader
Ensure Trainee/student activities when applicable
Ensure activities regarding periodic review
implementation of external documents in accordance with local/corporate procedures,
Assure the monitoring and tracking of external documents.
Ensure training records are maintained
Deliver documentation training, as applicable
Provide support during internal (Corporate), Regulatory Inspections and external audit.
Provide support to activities in the scope of quality system when needed.
Participate to improvements related to Documentation activities
Create new part in SQLM as per supplier quality group request
Ensure on-time publication of Lessines Management Review and Annual Product Quality Review
Give support to labeling team with proofreading of on-line printed labelsMaintain its Standard leader work in a monthly basis.
Maintain and improve 6S in her working area
Ensure the 6S and all visual management of the ‘doc’ department
Number of years of experience: minimum 2 years in related industry.
Administrative Task and good knowledge in English and French
Good knowledge in Microsoft office / Outlook and Trackwise / Elan /AS400 / TCU / Access / Adobe Acrobat
Is organized, has analytical and critical mindset.
Good communication skills: interact efficiently with all stakeholders.
Team spirit minded.
Dedicated to Quality.
Accountable and integer.
Dynamic and motivated.
Fluent in English.
Knowledge of Quality Systems.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Our products and therapies touch the lives of millions of people around the world every day, which is why we are focused on transformative innovations that bring smarter, more personalized care to all of us. For 87 years and counting, we have been at the critical intersection where the ideas that save and sustain lives meet the providers who make it all happen. And now, we are determined to realize our boldest opportunities to transform global healthcare for years to come.