Job Title: Quality Assurance Specialist
Location: Sanford, NC
Duration: 18+ Month Contract
Job Responsibilities:
Supports the Client's Sanford, NC, Quality Operations department by performing Quality Assurance activities including suppler qualification and management, and enrollment of new materials and suppliers associated with clinical and/or commercial products. In addition, may support regulatory agency inspections.
Role Responsibilities:
Individual Accountabilities:
• Perform QA assessments and approvals for supplier management.
• Contributes to the interpretation of cGXPs for the commercial and clinical environment.
• Able to resolve complex issues with minimal assistance from management.
• QA supplier management activities (supplier reassessments, quality agreements, audit reviews, risk assessments)
• QA support and approval for qualification of new suppliers and materials
Shared Accountabilities:
• Support external agency audits
• Develops ability to train other team members on tasks
• Identify and implement new processes and programs for quality improvement.
• Interfaces with other parts of the organization such as Pharmaceutical research and development groups. Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.
• Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.
Education or Equivalent:
BA or MS in a science/related field or equivalent education and/or pharmaceutical work experience.
Technical Competencies:
Knowledge in cGXP, materials, components, and supplier management.
Behavioral Competencies:
• Demonstrates business acumen
• Change agile
• Seizes accountability
• Holds people accountable
• Self-Awareness
• Creative thinker
Organizational Relationships:
Reports into the Manager, QA Supplier Management. Interacts with the Sanford QA Supplier Management team, Global Procurement, Site Supply Chain, Technical Operations, Production, other Pharmaceutical Sanford departments and other Pharmaceutical PGS sites. Will also interact with 3rd party suppliers and service providers.
Resources Managed:
• Continuous improvement of processes
• No direct reports
Hard Skills:
1. GMP Systems
2. MS Office
3. Critical thinking/problem solving
Preferred Skills:
1. Team Player (Diverse Team)
2. Positive Attitude
Interview Process:
Panel Teams (Camera-On)
