What are the responsibilities and job description for the Supplier Quality Assurance Specialist position at Integrated Resources, Inc?
Job Description: Role Summary:
Supports the *** 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 *** 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 *** Sanford departments and other *** 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
Supports the *** 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 *** 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 *** Sanford departments and other *** 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
