Quality Systems Specialist

Job Description

The Quality System Specialist II – Change Control is accountable for support of the continued development, deployment, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product/process resolution decisions and project teams for process improvement and continuous improvement activities. The position requires strong leadership abilities, problem solving skills, strong verbal and written communication skills as well as strong organizational capabilities.

• 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.
• Perform 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.
• Acts as 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.
• Serves as change leader and regulatory liaison ensuring changes meet necessary compliance.
• Manages the Change Control Review Board making sure all changes are reviewed by the board.
• Manages Deviation Administrator, including the review board meetings, and ensuring all deviations are compliant.
• Follows up for deviation administration such as on-time closure or extensions to remain in compliance.
• Manages Monthly Quality Metrics required for compliance to local procedure.
• Maintains constant communication with EU Quality team for any information required by the Qualified Persons along with continuous monthly change control reporting.
• Follows up for approval and implementation of corrective actions for CAPA, External and Internal Audits findings, Customer Complaints, Quality Notifications, and Deviations.
• Assists in internal and external audits.
• Coordinates and compiles APR (Annual Product Review) and PQR (Product Quality Review) reports for domestic and international product codes.
• Assists with the Post NDA Annual Report.
• Assists with the technical submissions used for international regulatory agencies.

Bachelor’s degree with 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, PowerPoint, 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.

Primary

Work Location:

USA, TX – El Paso – Northwestern Dr.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.