Quality Associate

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.

Maintain change control system for Multisource quality function to assure compliance and consistency with Regulatory applications. Maintain archives for supplier change notifications.
Generate annual change reports for each site to aid in the production of the Annual Product Reports by Regulatory Affairs.
Assist in data entry for Annual Product review software application to support Product Annual Reviews. Generate quarterly trend reports for site scorecard evaluations.
Assist in Quality documentation archive for Multisource business including validation documents, product profiles, regulatory agency inspection documents, change controls, batch review documents, etc. Coordinate destruction and off-site storage as needed.
Monitor commitments for completion by due dates and maintain files with closure documents.
Assign exception report numbers and track these documents to 30-day closure requirement, including entry of corrective action commitments into tracking system.
Aid Supplier Assessment group with observation tracking and closure as needed.
Assist in scanning of supplier documents to be stored in the Qumas repository system.
Assist in FDA inspection readiness as necessary.


Qualifications
Requirements:

Must possess attention to detail and the ability to follow-up on projects to closure.
Must possess good communication skills to interact with many departments on a frequent basis.
Must have excellent computer skills, including use of scanner and willingness to adapt to new software applications.
Must be able to think globally and offer suggestions for improvement.

Qualifications:

BA/Bs in Science area. Minimum 3 years experience in the pharmaceutical industry, preferably Quality Assurance. Familiarity with cGMP environment and quality systems requirements including SOPs.


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