Quality Systems Specialist

Responsibilities

• Works with various departments to support SAP ACR/ECR/ECO implementation process throughout the organization
• 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/O strategies for all SAP implementations ensuring all changes are compliant and executed on 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
• Deviation Administrator managing all deviations including the review board meetings and making sure all deviations are compliant
• Follow up for deviation administration such as on-time closure or extensions to remain in compliance
• Manage Monthly Quality Metrics required for compliance to local procedure
• Manage 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
• 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
• Aid with technical submissions used for international regulatory agencies

Qualifications

• Bachelor’s degree
• 4 years relevant experience or a combination of equivalent education and relevant experience
• Moderate level of application of Quality system standards to assigned Quality system area
• 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 preferred - English, Spanish
• Experience in FDA, GMPs and ISO requirements
• Experience with SAP preferred
• Experience in Lean/Six Sigma preferred