Position: Supplier Quality Assurance Specialist
Location: Sanford - Oak Park, NC
Duration: 18 months
Schedule: M-F 1st Shift
Job Description:
- Supports the Client 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.
- Support regulatory agency inspections.
- 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.
- 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 Client 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.
Resources Managed:
- Continuous improvement of processes
- No direct reports
Hard Skills: