at Baxter Healthcare Corporation in Round Lake, Illinois, United States
Job Description
This is where you save and sustain lives
At 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 Baxter:
Vital role in the Project Management Office, responsible for the market introduction of new Baxter drug products. Review and approve documentation to support timely product and system release. Assist and guide functions in the preparation of new product documentation, product configuration and document change request package development. Assist in providing training on documentation processes and systems. Participate on project and process improvement teams as needed.
What you'll be doing:
Own change controls and drive ownership and completion of change control action items.
Own the creation of new product documentation (forms, SOPs, batch records) and drive approvals. Work with area subject matter experts (SME) to redline and update documents.
Drive Certificate of Analysis finalization working with the chemistry lab and SMEs.
Document configuration and product data management.
Review documentation for accuracy and compliance to procedures. Release or reject as appropriate. Ensure all document and system elements are identified, accurate and assembled for review and approval.
Aid in the creation / writing of training materials.
Assist in training internal and external personnel on documentation related processes and systems.
Maintain and own internal documents.
Assist in audit readiness efforts and actual audit events.
Perform data and document management entry and processing in the Baxter document system of record.
What you'll bring:
Experienced in the use of document management systems; will own and lead plant change controls associated with product launches.
Product / document configuration. Intermediate level of desktop publishing skills and document management software skills.
Basic Graphic / Illustration software skills.
Project management skills.
Page layout fundamentals. Understanding and effective usage of corporate graphics standards for packaging labeling.
Excellent conceptual, analytical, written and verbal configuration skills.
Comprehension of design methodology, product configuration and complex manufacturing processes.
Ability to work under strict deadlines and changing priorities with minimal direction. * Strong interpersonal skills and phenomenal attention to detail are necessary.
Must be a strong teammate with good problem solving, and good verbal and written communication skills.
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
High school diploma or GED with 4 or more years' experience with Baxter Product Data Management/documentation systems or equivalent change control system. Knowledge of product data/document configuration management a plus.
Working knowledge of Quality Systems is a plus
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $52,800 to $86,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location
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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in... For full info follow application link.
Equal Employment Opportunity
Baxter 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.
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