BD (Becton, Dickinson and Company) Quality Systems Specialist II - Document and Data Management in Sparks, Maryland
Job Description SummaryThe Quality Systems Specialist II - Document and Data Management is responsible for change coordination and control for BD Diagnostic Systems business unit in compliance with FDA, ISO, and other applicable regulations.
He/she facilitates the engineering change management process, ensuring complete, consistent implementation of changes. The position has a broad business perspective across different plant-level process areas involving controlled documents and master data objects, combined with in-depth understanding of BD’s ERP and engineering change control environment.
The Quality Systems Specialist II - Document and Data Management also participates in the implementation of process improvement and upgrade initiatives, with a focus on DS-wide process standardization and efficiency.
Works with engineering, operations, and master data coordinators to identify controlled documents and SAP master data objects (material masters, bills of materials, task lists, etc.) that will be impacted by proposed changes.
Works with engineering change requesters to determine change implementation (ECO) strategies.
Acts as change coordinator in BD’s SAP Product Lifecycle Management (PLM) system.
Verifies that appropriate individuals are assigned to tasks in the ECR/O process; adjusts task assignments in coordination with change requesters and functional leaders; maintains underlying design center matrix and related reviewer / approval matrices.
Ensures that change packages are complete for release / implementation, i.e. all necessary supporting documents and data objects are in place and all affected controlled documents and master data objects have been reviewed and approved for adequacy by appropriate individuals; releases controlled documents and master data objects for use.
Interfaces with BD manufacturing plants and other business functions to ensure complete, consistent, and timely implementation of changes.
Will provide a variety of document control functions for documentation maintained outside of SAP in other systems, including paper files.
Generates metrics on performance of the Documentation Control function including turnaround time.
As the SME, will provide End User support.
Function as Lead Trainers by facilitating training in 1:1 and group settings and maintain current training job aids.
Work within a team environment to continuously meet internal customer expectations for documentation services by balancing the volume of work, maintaining and following procedures and driving for continuous improvement in accuracy and turnaround time.
Functions as system administrator in the training system, C2C. Responsible for running, reports and updating curricula. Perform training for new C2C administrators and provide back-up support for DLAs during inspections.
Completes additional responsibilities as assigned by QA management
MINIMUM QUALIFICATIONS :
KNOWLEDGE AND SKILLS:
Knowledge of FDA/ISO regulations related to document and data control
Knowledge of SAP change management and master data concepts
Solid PC skills in MS Office and other reporting and productivity tools
Attention to detail, careful, deliberate, disciplined, meticulous
Effective organizational and planning skills; able to manage multiple documentation packages at the same time.
Analytical skills and strong problem solving abilities
Proactive skill set to prevent data integration issues from occurring as well as action-oriented in bringing resolution to known data integration issues
Excellent written and oral communication skills EDUCATION AND EXPERIENCE:
AA or BA/BS degree in business, information systems, engineering or related discipline or equivalent and relevant experience.
2+ years’ experience in ISO / FDA regulated environments, preferably medical device industry, with exposure to document and data control processes like engineering change control, label and copy approval, etc.
2+ years’ experience utilizing electronic change control tools
Primary Work LocationUSA MD - Baltimore
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