QA AnalystBaxter

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.
1. Position is responsible for the development and completion of documentation on protocols, and Validation Summary Packages.
2. Handles in preparatory activities, planning and coordination work at all levels with regard to the validation task
3. Schedule, plan and manage documents and follow-up on validation projects including: new facility planning, construction and use, new equipment selection, acquisition, installation and use, facility/system/process improvements, modifications and additions, new product or new product changes and computer-based systems and software.
4. Assist in the creation of validation protocols and requalification programs, coordinate/perform the test activities necessary to execute the validations, reviews/summarize the results and conclusion of the validations, coordinate any software control activities used in the manufacture, testing approval or documentation of the product.
5. Executes process and non-process validation activities and M&TE Calibration.
6. Follows-up, collects, reviews and analyzes all validation data and test results
7. Performs contingent tasks related to or arising from the validation activity, such as but not limited to:
· Preparation of Investigation Reports
· Recommendation on revisions to SOP's
· Technical presentations to Validation Department or Technical Committee
· final turn-over to process owners
8. As needed, provides technical support for queries from management on non-process validation activities
9. Organizes and performs the logging and archiving of validation documents. Interpretation and application of regulatory requirements concerning validation activities.
10. May also direct or participate in: performing technical failure analysis on processes/product not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce product/process variability, and apply statistical analysis and design of experimental approaches to process development activities.
11. Works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
Reasonable Accommodations
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 [Protected Info] and let us know the nature of your request along with your contact information.
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Baxter

Calamba City, Laguna
Permanent
Full-time