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Quality Analyst - Cali, Colombia - Baxter
Descripción
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:
The Quality Analyst plays a key role in supporting the external contract manufacturing Quality organization at Baxter by:
What you'll be doing
1
• Review and approve manufacturing records (batch and DHR records) for products manufactured by other Manufactures suppliers Organizations to ensure accuracy and completeness. This may include a review of Minor nonconformance reports related to the manufacture of these products.
2
• Generate Baxter Certificates of Conformance and Certificates of Analysis (CoC/CoA) for these products when required.
4
• Use electronic systems (e.g., Trackwise) for maintaining supplier quality records and uploading requirements.
5
• Assist with periodic supplier requirement reviews by confirming and/or acquiring quality requirements such as quality agreements, surveys, or quality certificates.
6
• Assist with supplier-related change control tasks as assigned/required.
7
• Assist with controlled document revisions as needed.
8
• Assist with automated Bot performance monitoring (and associated IT validation activities as required).
9
• Support supplier access requests to Baxter Certificate Repository.
10
• Assist with Baxter and supplier batch record retention/archival as needed.
11
• Help with external product complaint sample shipment coordination.
12
• Participate in continuous improvement activities and projects (i.e., CAPA, Pr oduct Improvement teams). May lead projects assigned by management.
13
• Interpret and complete policies and procedures that affect the organizational unit.
14
• Interact frequently with functional peer groups, area management, and Baxter's suppliers.
• Manage workflow: identify and raise issues as needed.
What you'll bring
1
• Bachelor's degree in Pharmaceutical Chemistry or related
Alternately, a combination of equivalent education and experience will also be considered.
2
• (1 – 3) years of experience working in the pharmaceutical, medical device, or biotech industry preferred.
3
• Familiarity with regulatory (e.g., U.S. FDA) and ISO 13485 requirements preferred.
4
• Prior experience working with SharePoint, Microsoft Office applications, Warehouse Management system, reviewing manufacturing batch records/DHR documents, and reviewing/approving Minor nonconformance investigations related to finished goods preferred.
5
• Fluent in English (mandatory)
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