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Senior Quality System Specialist

Apply Now Job ID R-335043 Date posted 04/17/2019

Job Description Summary

Job Description

Reporting to the Associate Director of Corporate Quality, the Sr. Quality System Specialist is accountable for supporting validation, implementation and change management of key quality IT systems.  The incumbent works on assigned IT quality system projects as the validation and compliance expert to ensure efficient project execution and compliance with BD computer system validation policy and IT SDLC procedures.  The Sr. Quality System Specialist will provide guidance to the business owner, process owner, and end-user stakeholders throughout the IT demand portfolio process (Idea to Realization – I2R) and SDLC process.  This includes, but not limited to, key quality and regulatory systems such as LIMS, Trackwise, Blue Mountain, Regulatory Information Management (RIM), Product Information Management (PIM).  In this role, the Sr. Quality System Specialist will work with the businesses and project team to create and approve key validation documents such as User Requirements Specification, Functional Requirements Specification, Risk Assessment, Validation Plan, Part 11 Assessment, OQ/PQ test scripts, Traceability Matrix and Validation Summary Report.  Through outstanding communication; effective problem solving and organizational skills; the Sr. Quality System Specialist will help 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.

RESPONSIBILITIES:

  • Assume the GxP SME / Quality Representative role on assigned quality or regulatory IT system implementation project to provide validation guidance and oversight to ensure projects are compliant with BD computer system validation policy and IT SDLC procedures.
  • Provide guidance on validation of local business application, database/spreadsheets, and lab equipment at the business unit or site level.
  • Ensure project activities and deliverables are executed in accordance with internal BD policies and procedures such as IT SDLC, validation and change management.
  • Author or provide quality approval of key validation documentation including, but not limited to, User Requirements Specification, Functional Requirement Specification, Risk Assessment, Validation Plan, requirement-based OQ/PQ test cases, Traceability Matrix, Validation Summary Report.
  • Provide guidance and recommendation for right-sizing validation scalable the risk and complexity of the systems.
  • Provide quality guidance on projects following either water fall or agile SDLC methodologies.
  • 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 OQ, PQ, data verification, and defect handling for different quality IT systems.
  • Lead, support, and perform vendor audits
  • Perform periodic and/or preventive audits on the key quality and regulatory IT systems to make sure validation and change management are adequate to maintain the validated state of these systems.
  • 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.

QUALIFICATIONS:

  • A minimum of a bachelor’s degree required in Computer Science, Information Technology, Engineering, or Science discipline.

  • A minimum of 3 years or practical experience and proficiency with System Development Life Cycle (SDLC) in a regulated environment (medical device or pharmaceutical) for IT systems supporting quality management system (QMS).
  • Practical knowledge of 21 CFR 820, ISO 13485, 21 CFR Part 11, GAMP5, and good documentation practices.
  • Practical knowledge with Trackwise, LIMS, SAP, Training system, Blue Mountain, Documentation Management System is a plus.
  • There is an equally important set of leadership skills needed to perform this role.  They include project management, influence management, communication effectiveness, and facilitating conflict resolution.
  • Effectively / actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
  • Demonstrated ability to perform multiple tasks / large projects and to prioritize work load for function.
  • 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.
  • Self-motivated/directed.
  • Ability to travel up to 10% 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 Location

USA NJ - Franklin Lakes

Additional Locations

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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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com