QA Analyst, PQS

Fujifilm - Holly Springs, NC

Full-time - Entry Level

Holly Springs, NC

Machinery Manufacturing

About the position

The QA Analyst, PQS plays a crucial role in ensuring quality oversight of PQS applications within the Enterprise Quality Systems at Fujifilm's state-of-the-art Life Science Manufacturing Facility. This position involves collaboration with various project teams and QA departments to maintain consistent policy administration and assist in daily quality assurance activities. The QA Analyst is responsible for monitoring procedures, documenting test results, and participating in audits, all while supporting the manufacturing of biopharmaceuticals that can make a significant impact on people's lives.

Responsibilities

• Supports QA for project deliverables in accordance with governing processes and procedures within the assigned Quality area.
• Participates in assigned audits on a regular basis.
• Reviews and approves test plans and protocols for the validation approach and lifecycle documents.
• Monitors procedures, reports, and processes errors.
• Documents and communicates test results, defects, and deviations.
• Participates in risk assessments and assists in mitigating quality-related risks.
• Provides administrative support for the QMS system, as required.
• Performs other duties, as assigned.

Requirements

• Bachelor's Degree in Life Sciences (e.g., Engineering, Applied Science or Chemistry) with no previous experience.
• Basic experience or understanding of GMP, GLP, GDP requirements.

Nice-to-haves

• Prior experience in GMP environment.