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Quality Assurance Specialist

1 month ago

Sanford, Florida, United States Net2Source Inc. Full time

Job Title: Quality Assurance Specialist

Location:

Duration: 18+ Month Contract

Job Responsibilities:

Supports the Client's Quality Operations department by performing Quality Assurance activities, including supplier qualification and management, and enrollment of new materials and suppliers associated with clinical and/or commercial products. Additionally, may support regulatory agency inspections.

Key Responsibilities:


• Perform QA assessments and approvals for supplier management.


• Contribute to the interpretation of cGXP regulations for the commercial and clinical environment.


• Resolve complex issues with minimal assistance from management.


• Conduct QA supplier management activities, including supplier reassessments, quality agreements, audit reviews, and risk assessments.


• Support and approve the qualification of new suppliers and materials.

Shared Responsibilities:


• Assist with external agency audits.


• Develop the ability to train other team members on tasks.


• Identify and implement new processes and programs for quality improvement.


• Interface with other parts of the organization, including Pharmaceutical research and development groups, and work outside immediate subject areas to support a wider range of customers with differing subject areas and locations.


• Represent 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.


• Embraces change.


• Takes ownership of responsibilities.


• Holds others accountable.


• Exhibits self-awareness.


• Displays creative thinking.

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. Also interacts 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).