Coord 1, Quality Document Sys Mgmt

Quality Document Systems Management is responsible for the development, deployment and maintenance of controlled documentation and supporting systems. Typically is vocationally qualified with limited work experience. Develops knowledge and skills in basic practices and procedures within own area. Applies basic technical skills and knowledge to complete assigned work. Works on straightforward tasks using established procedures; work is subject to review by others.

Depends on others for instruction, guidance and direction.

• Typically requires a minimum of a bachelor's degree
• 4 years relevant experience or a combination of equivalent education and relevant experience.

• Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements.
• Computer proficiency in Microsoft office (Word, Excel, Power Point, Project, Outlook).
• Good team player skills.
• Bilingual - English, Spanish
• Experience in FDA, GMPs and ISO requirements.
• Experience with SAP preferred.
• Experience in Lean/Six Sigma preferred.

Sitting and work on computer, moderate work on the production floor, moderate walking.

• Serves as the main point of contact for PEGA/Teamcenter and as the SME for the Change Control process.
• Works with various departments to support SAP ACR/ECR/ECO implementation process throughout the organization
• Works within and across functions to support the Change Control process throughout the organization.
• Performing tasks, of moderate complexity, within planned schedules and timelines, supporting audits, actively leading or participating on project teams, ensuring change control documentation compliance
• Follows applicable Company / Unit procedures and may make updates to procedures and policies.
• Collaborate with QA resources to ensure compliance to FDA and Foreign Regulatory Agencies
• Engineering Change Order Administrator reviewing and implementing ECR/ECO strategies for all SAP implementations ensuring all changes are compliant and executed in a timely manner.
• Change leader and Regulatory liaison ensuring changes meet necessary compliance.
• Manage Change Control Review Board making sure all changes are reviewed by the board
• Manage Monthly Quality Metrics required for compliance to local procedure.
• Maintain constant communication with EU Quality team for any information required by the Qualified Persons along with continuous monthly change control reporting.
• Follow up for approval and implementation of corrective actions for CAPA, External and Internal Audits findings, Customer Complaints, Quality Notifications, and Deviations when change control support is applicable.
• Assist in internal and external audits.
• Coordinate and compile APR (Annual Product Review) and PQR (Product Quality Review) reports for domestic and international product codes.
• Assist with the Post NDA Annual Report.
• Assist with the technical submissions used for international regulatory agencies.
• Supports the training function to ensure trainings are performed for proper change control closure