Skills Needed

Description

SourceAbled is seeking candidates for a 1st shift contract role as a Quality Assurance Specialist with our client Pfizer, one of the world’s largest pharmaceutical companies. Seeking candidates in Sanford, NC or willing to relocate.

Role Summary:

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. In addition, may support regulatory agency inspections.

Role Responsibilities:x

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 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.

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 Client Sanford departments and other Client PGS sites. Will also interact with 3rd party suppliers and service providers.

Resources Managed:

• Continuous improvement of processes
• No direct reports

Hard Skills:

• GMP Systems
• MS Office
• Critical thinking/problem solving

Preferred Skills:

• Team Player (Diverse Team)
•  Positive Attitude