Quality Assurance Specialist

Job Description

Job description

Responsibilities:

• Performs a variety of QA activities to ensure compliance with applicable regulatory requirements and Kite procedures.

• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).

• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.

• Contribute to the Quality on the floor processes, including GEMBA walks and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), and Kite procedures.

• Provides support to deviation lead/coordinators for deviations investigations and corrective and preventive action (CAPA) relating to manufactured products and contributes to the QA review and approval process of deviations and CAPA.

• Identifies and reports   deviations from approved processes and procedures  to senior colleagues

Projects involvement:

• Works on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.

• Perform other duties as assigned.

Requirements:

Knowledge and skills:

• Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Demonstrates basic knowledge of FDA / EMA standards and quality systems.

• Demonstrates good verbal, written, and interpersonal communication skills.

• Demonstrates working knowledge in Microsoft Office applications.

Education & Experience:

• 2+ years of experience in a GMP environment and a BSc degree.

• Or 3+ years of experience in a GMP environment and Associated degree. (2 years undergraduate)

• Prior experience in pharmaceutical industry or similar bio industry is beneficial.