Quality Assoc I

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) Reviews documentation for accuracy and compliance to procedures, and release or reject as appropriate. Obtain resolution on areas identified as non-conformance. Interpret and evaluate results in terms of acceptability to standards, procedures, and regulatory requirements. Provides the final say in product release to the field or to internal customers.


2) Creates lots in computer data tracking systems, such as LIMS, and issues labels, batch records and packaging releases.


3) Controls storage and retrieval of batch related documentation and the QM Release vault.


4) Completes Certificates of Analysis and Test Protocols for released products.


5) Tracks product releases in the Release Departments tracking system.


6) Attends/supports daily fulfillment meetings and works with the Planning Department in order to understand and meet customer requirements.


7) Interacts with Manufacturing, QM Operations, Laboratories, and other
departments, as needed, to release product to internal and external customers.


8) Contributes to developing and maintaining all QM Release procedures, forms, checklists, and Certificates of Analysis.


9) Initiates SOP revisions, as needed, to support continuous improvement.


10) Ensures product compliance regulations are followed.


Qualifications
1) Working knowledge of PC based systems including Access, Word and Lotus Notes.


2) Demonstrated understanding of quality assurance in an FDA-regulated environment.


3) Effective organizational, technical and problem solving skills.


4) Strong communications skills (written and verbal) to effectively communicate with all levels of management in the facility.


5) Good time management skills.



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