BD (Becton, Dickinson and Company) Senior Quality System Specialist in Franklin Lakes, New Jersey
Job Description Summary
Reporting to the Associate Director of Corporate Quality, the Sr. Quality System Specialist works on assigned IT quality systems projects to be the business analyst and liaison between the businesses and IT to implement the IT solutions that meet the business’s needs. This includes, but not limited to, key systems such as LIMS, Trackwise, and Blue Mountain. In this role, the incumbent works with the businesses and plants to execute the design and implementation of local master data (e.g. product, test methods, equipment, and calibration data). Through outstanding communication; effective problem solving and organizational skills; the incumbent helps Corporate Quality group in implementing and expanding the usage of key quality IT systems that are compliant with internal BD procedures and relevant global regulations. Success is measured in supporting the project teams and sites to deliver the needed solution and deliverables on the annual basis.
Provide hands-on support to businesses and plants in designing and implementing local master data based on business workflow for key quality IT systems such as LIMS, Trackwise, and Blue Mountain.
Work directly with the businesses and plants in defining roadmap/strategy for update and enhancement on key quality IT systems.
Provide oversight, guidance and execution of PQ and data verification for different quality IT systems.
Ensure project activities and deliverables are executed in accordance with internal BD policies and procedures such as IT SDLC, validation and change management.
Responsible for reviewing and approving validation deliverables of GxP regulated computerized systems.
Work on different GxP regulated computerized systems projects as the GxP SME (subject matter expert) to provide quality guidance and approve validation documents.
Provide user and administrative support for systems that Quality owns (e.g. 21 CFR Part 11 sharepoint, Blue Mountain).
Monitor, measure and improve the efficiency and effectiveness of the implementation these key quality IT systems.
Performing other related duties and assignments as required.
A minimum of a bachelor’s degree required in Computer Science, Information Technology, Engineering, or Science discipline.
A minimum of 2 years of practical experience with System Development Life Cycle (SDLC) for IT systems supporting quality management system (QMS).
Must have practical knowledge in manufacturing and laboratory testing of medical device products.
Practical knowledge as a super user with SAP and LIMS systems is preferred.
Excellent analytical, technical, and problem solving skills.
Ability to influence without authority at different levels of the organization.
Excellent and experienced meeting and presentation skills.
Demonstrated ability to perform multiple tasks / large projects and to prioritize work load for function.
Effective in managing conflict and seeking effective solutions.
Ability to travel 25% of the time both domestically and internationally.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsMEX Mexico City - Lomas de Chapultepec
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status