Job Description: Summary
As directed by the Quality Manager, the Quality System Specialist I is accountable for support of the continued development, improvement and implementation of the Quality Systems as well as maintaining compliance with regulations, standards, and Corporate requirements. This position is responsible for the coordination and management of the document control and change management process and related systems, including ACR Assessment of Change Request, ECM Engineering Change Management, and DMS - Document Management System. The Quality System Specialist I is the subject matter expert in these areas and has the local responsibility for ensuring complete and consistent implementation of changes.
Responsible for governance of the change management process to ensure accuracy, efficiency, and compliance. Works with project leaders and team members to determine change implementation strategies (ECR/O - Engineering Change Request/ Order) and to identify/collect controlled documents and SAP master data objects that will be impacted by proposed changes.
Ensures that change packages are complete for release/ implementation according to ECR strategy and system requirements. Manages workflow tasks and verifies that appropriate individuals are assigned to tasks in the ECR/O process. Develops and delivers training to associates on ECM and DMS and provide guidance and support to end users, including system troubleshooting and issue escalation.
Design Center Specialist
Responsible for accuracy of the design center structure in order to maintain the associated processes (change control and document security) effective and efficient. Maintains underlying design center matrix and related reviewer/ approval matrices.
C2C Administrator and CUP (Compliant User Provisioning) Super User
Responsible for management of the C2C (Compliance to Capability) Learning Management System. This includes maintenance of training records and curriculum related to Quality System and SAP. As CUP Super User, is responsible for administration of new role requests in SAP.
Responsible for identifying and implementing improvements to the overall document control and change management process.
Responsible for the quality and accuracy of the Quality records including document security.
KSA Requirements (Knowledge, Skills, and Abilities):
Limited / Basic application of Quality systems principles and concepts ( e.g. Document control).
Limited knowledge of applicable Regulatory, Corporate and/or Unit requirements.
MINIMUM QUALIFICATIONS AND REQUIREMENTS
Required: Associate's degree in related field
Preferred: Bachelor's degree in related field
Required: Minimum 3 years relevant experience with Associates, 1 year with Bachelors.
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
BD (Becton, Dickinson And Company)