Quality Systems Specialist II - 1st Shift

Quality Systems Specialist II - 1st Shift

Join to apply for the Quality Systems Specialist II - 1st Shift role at BD (Tissuemed Ltd)

Job Description Summary

The primary function of this position is to support the maintenance of site wide compliance and the Quality Systems; such as: hosting customer audits, performing internal audits, corrective action and preventative actions (CAPA), develop and deliver training and perform root cause investigations with the ability to offer sustainable actions.

Document Control focus area is responsible for the coordination and management of the BDM, PS Columbus document control system and the implementation of the SAP document structures. Is the subject matter expert for the Columbus BDM, PS document control system and has the local responsibility for the development, implementation, and improvements of the document system as well as maintaining it in compliance with ISO, cGMP, BDM, PS and BDX requirements.

Interfaces directly with BDM, PS sites in Franklin Lakes, Pont de Claix, and Cuautitlan, and the BD Corporate Document group on document control matters.

Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values.

Responsibilities

• Provides assistance with hosting customer audits, maintaining minutes, generating reports for customers and tracking actions through completion.
• Effectively represent BD in customer facing role during audits.
• Conducts internal audits with lead auditor responsibilities.
• Maintain metrics for the quality systems and perform data review which may lead to CAPA.
• Perform root cause investigations for customer complaints including report generation and follow up on actions.
• Support site and Worldwide quality boards (audits, CAPA, and CIR) and Management Reviews in data capture/review and report generation and tracking of actions in a timely manner. Utilize Trackwise or other tracking systems and be able to perform user training of the system.
• Actively coordinate and follow up on actions to meet due dates.

Document Control Focus Area

• Brings a high level of manufacturing process and Quality Systems understanding to the review and approval process and has the authority to reject documentation packages when they do not comply with process or system requirements.
• Ensures that document types and formats submitted for approval are compliant with BDM, PS and BDX requirements as well as compliance to required approval routings and has the authority to reject document packages when these requirements are not followed.
• Develops and delivers training for associates in use of documentation system and the Engineering Change Order process and mentors users in the document control process.
• Responsible for the quality and accuracy of the site Electronic Document System (eDoc) including security for access to the system, creation/maintenance of menus, placement of documents (pdf format) on local server, and application of security to block print capability on designated documents.
• Provides Help Desk support to users of documentation system. Includes creation and monitoring of incident tickets requiring help desk support from System Administrator.
• Provides timely review and approval of all site document revisions/creations and associated Engineering Change Orders (ECOs). Primary document control approval signature for all document and EDO routings.
• Assists change originators in coordination of document releases.
• Coordinates the site 3‑year review program by providing a rolling one year schedule of documentation requiring review, and providing a report to the plant leadership team on departmental and overall compliance to the process.
• Maintains:
  Site document templates, user accounts, site procedures related to document control and table of content, archive area specific to the document control group, document legacy systems, databases used for document system (e.g., TWI Log and Report Card, Document Distribution, Document…