Specialist, Quality Control Microbiology

Role Summary

Specialist, Quality Control Microbiology. Manage Quality aspects of clinical programs and projects within area of responsibility. Ensure and support overall GxP conformity and Compliance with the Novartis Quality Management Systems. Identify and execute on OpEx opportunities. Build/manage stakeholder relationships and expectations. Location: Durham, NC. This role is on-site 5 days a week and does not support remote work.

Responsibilities

• Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting
• Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner
• Support and track the implementation and maintenance of the local Quality system in accordance with the Novartis Quality Manual
• Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management
• Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality
• Contributes to an improvement of current processes and/or to an implementation of modified processes
• Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), including escalation of issues related to the closure of CAPA
• Review quality deliverables to ensure compliance with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments
• Prepare and review GxP documentation; assist in the release of GxP documentation, filing and archiving of GxP documentation
• Support Compliance review of projects and inspection readiness and management
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Qualifications

• Work Experience: Functional Breadth
• Collaborating across boundaries
• Operations Management and Execution
• Project Management

Skills

• Agility
• Audit Management
• Business Partnering
• Change Control
• Continuous Learning
• Health Authorities
• Influencing Skills
• Knowledge Of CAPA
• QA (Quality Assurance)
• Quality Management
• Quality Management Systems (QMS)
• Risk Management
• Root Cause Analysis (RCA)
• Self Awareness
• SOP (Standard Operating Procedure)
• Technological Expertise

Languages

• English