Quality Assoc III
Van Nuys, CA
Req ID 50643BR
Business Title
Quality Assoc III
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Van Nuys, CA
Shift_
1st
Job Description
•Monitor Product Specifications, Standard Operating Procedures, Direction Inserts, Assay Validity Reports for domestic, Japanese and European subsidiaries for changes, which may affect stability requirements, stability data, or interpretation.
•Assist in designing stability test protocols to support product stability claims for registration with worldwide regulatory agencies.
•Work with various Quality Assurance, Product Development, Quality Control, Test Development and Research personnel to assure that testing methodology is consistent, reliable, stability indicating and appropriate as required by worldwide agencies.
•Manage Stability studies for licensed, development and contract manufacturing products to assure acceptability for worldwide product registration.
•Review stability data for correctness, for compliance with cGMP/GLP/GDP requirements, and for consistency with previously generated data.
•Monitor Stability studies for completion, alert testing laboratories to priorities, and provide monthly overdue list of tests to be completed.
•Review, track, and analyze stability data generated by subsidiaries and prepare monthly status reports.
•Maintain and update computer programs and data files to analyze and monitor stability data.
•Assist Manager in drafting stability reports and expert overviews.
•Participate in the training and guidance of new Stability personnel.
•Prepare and issue Stability reports for submission to regulatory agencies.
•Maintain TDTS Training history records and training files.
•Assist management during internal/external audits, audit responses, CAPA development and completion.
•Work on special projects as assigned by the director or managers.
Job Requirements
•Computer skills required.
•Good verbal and written communication skills.
•Ability to participate in special project teams.
•Good technical writing skills are recommended.
•Familiarity with physical chemistry, physical pharmacy, protein chemistry concepts preferred
•A background in a broad range of analytical chemistry/biochemistry techniques would be a definite plus
•Prior work experience or training in cGMP, GDP and GLP. M.S. with 3 or more years of relevant industry experience Preferred
B.S. minimum in Pharmaceutical Sciences/Biochemistry/Immunology or related field with 3 or more years of relevant industry experience.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
