QA Analyst

Fujifilm - Holly Springs, NC

Full-time

Holly Springs, NC

Machinery Manufacturing

About the position

The QA Analyst plays a crucial role in ensuring quality oversight during the Drug Substance Manufacturing process at FUJIFILM Diosynth Biotechnologies. This position involves collaboration with various teams to maintain consistent quality standards and address operational issues, contributing to the successful manufacturing of biopharmaceuticals.

Responsibilities

• Supports QA for project deliverables in accordance with the governing processes and procedures within the assigned Quality area.
• Participates or supports assigned Quality audits as applicable.
• Reviews and approves batch processing documentation.
• Assists with reviews and approval of Standard Operating Procedures and Work Instructions.
• Participates in risk assessments and assists in mitigating quality-related risks.
• Reviews and approves records within the eQMS such as Change Assessments and Investigations.
• Other duties as assigned.

Requirements

• Bachelor's Degree with scientific discipline (e.g., Engineering, Applied Science or Chemistry) with 0-2 years of experience.
• Basic experience or understanding of GMP, GLP, GDP requirements.

Nice-to-haves

• Experience in a GxP pharmaceutical manufacturing environment and/or biopharma startup environment with QA experience.