QC Microbiology Analyst I — GMP, Bioburden & Sterility

FUJIFILM Biotechnologies; Holly Springs (NC); Sur place; USD 55 000 - 75 000; Plein temps

Résumé du poste

FUJIFILM Biotechnologies seeks an Analyst 1, QC Microbiology to perform microbial testing of in-process drug substances, drug products, EM/UM, and raw materials under supervision in a GMP environment.

You will assist with documentation, training, and on-boarding while contributing to method validation, trend analysis, and CAPA activities to uphold quality and regulatory compliance in a fast-paced, 24/7 manufacturing setting.

Qualifications

• Bachelor's degree in a scientific discipline with 0-1 years of experience.
• Understanding of GMP, GLP, GDP requirements.

Responsabilités

• Performs microbial testing of in-process and finished products, raw materials, and environmental samples.
• Participates in writing or assisting with document preparation and review, training new staff.
• Supports CAPA implementation and trend analysis to improve assay reliability.
• Maintains laboratory instruments and resources, coordinates purchases of supplies.
• Ensures accuracy and security of laboratory data and compliance with regulatory standards.

Connaissances

Attention to detail

Strong communication

Problem solving

Structured planning

Formation

Bachelor's degree in Scientific discipline

Outils

MALDI systems

MicroSeq

TrackWise

Description du poste

FUJIFILM Biotechnologies seeks an Analyst 1, QC Microbiology to perform microbial testing of in-process drug substances, drug products, EM/UM, and raw materials under supervision in a GMP environment.

You will assist with documentation, training, and on-boarding while contributing to method validation, trend analysis, and CAPA activities to uphold quality and regulatory compliance in a fast-paced, 24/7 manufacturing setting.