Quality Coordinator

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
1. Ensure timely preparation/issuance of final product test certificates and protocols.

2. Perform final review of quality documentation to ensure compliance with SOP requirements/specifications and GDP.

3. Perform exception investigations, as needed.

4. Organization and establishment of documentation files.

5. Ensure department training records are accurate and up to date and maintain training information into ISOTrain system.

6. Assist with filing or completed batch/lot specific documents and maintenance of files.

7. Assist in initiating SOP changes per document change control process.

8. Issuance/tracking of quality document numbers.

9. General administrative tasks.


Qualifications
1. Must be familiar with cGMP and FDA requirements.

2. In-depth familiarity with all documentation requirements and standards for biological product.

3. Must be able to organize and analyze test data.

4. Ability to prioritize and make efficient use of time.

5. Must have computer skills in MS Word, MS Excel and MS Access.

6. Must be detail oriented, conscientious and have high reading skills, good analytical and problem solving skills.

7. Associate's degree or equivalent education is required. 2 to 4 years quality experience



As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits.




To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V