BD (Becton, Dickinson and Company) Sr. Quality Systems Specialist in San Diego, California
Job Description Summary
As directed by the Quality Manager, the Sr. Quality System Specialist is accountable for support of the continued development, improvement and implementation of the Quality Systems for the CTT (Custom Technology Team). This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to Custom Product Development and project teams for process improvement and continuous improvement activities.
This position also requires the Specialist to assist, as needed, in limited manufacturing operations when time sensitive projects are underway.
Primary Responsibilities and Dutie s
Consistent application of Quality system standards to assigned Quality system area (40%)
Develops solutions to routine assigned activities of moderate scope & complexity (20%)
Follows applicable Company / Unit procedures and may make updates to procedures and policies (10%)
Works within and across functions for assigned Quality systems and supports general CTT operations (20%)
Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements (10%)
May perform other duties as required
Scope of Responsibility:
Strategic Orientatio n:
Contributes to the completion of specific programs and projects.
Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers
Sphere of Influence:
Works under general direction.
Independently determines and develops approach to solutions.
Designs and performs development working independently within defined parameters with minimal supervision required
May provide guidance and work direction to lower level project developers
Develops solutions to routine assigned activities of moderate scope & complexity.
Reviews and approves CTT contract manufacturing design documentation to assure compliance to FDA requirements
Bachelor’s Degree required
Minimum of 5 years of experience with Quality Management Systems, with at least 1-2 years in a regulated environment
Familiar with ISO 9001 and 13458
Consistent application of Quality system standards to assigned Quality system area.
Working Knowledge of Quality Systems Regulatory requirements and application
Working knowledge of SAP
Knowledge of Validation processes preferred
Understanding of BDB products and typical customer applications, or knowledge of immunology and anti-bodies preferred