QC Analyst III, Microbiology

Fujifilm - College Station, TX

Full-time - Mid Level

College Station, TX

Machinery Manufacturing

About the position

The QC Analyst III, Microbiology is responsible for overseeing the microbiological aspects of cGMP compliance and testing at FUJIFILM Diosynth Biotechnologies Texas. This role involves performing various microbiological verifications, testing, and ensuring the laboratory is maintained according to industry standards. The position requires a strong understanding of aseptic techniques and the ability to analyze data while adhering to safety procedures.

Responsibilities

• Responsible for QC microbiological aspects of cGMP compliance and testing.
• Perform microbiological verifications for finished products and in-process controls.
• Qualification of microbiological media, diluents, and organisms.
• Conduct Biological Indicator Testing and qualification activities.
• Perform Material Bioburden Testing and Bioburden Suitability assessments.
• Conduct Bacterial Endotoxin Testing and Inhibition/Enhancement Testing for product samples and buffers.
• Identify bacteria using the Biology and Fungal Identifications by the Macroscopic Identification method.
• Perform Sub-Visible particulate Testing by USP methods.
• Participate in investigations and reviews of alert and action limit investigations, implementing corrective actions as needed.
• Contribute to the development and revision of microbiological Standard Operating Procedures (SOPs) and cGMP documentation.
• Review environmental monitoring and product release data.
• Maintain an organized, clean, and properly supplied laboratory environment.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in Biochemistry, Chemistry, Biology, or related field with 2+ years of relevant experience; OR Associate of Science with 3+ years of relevant experience; OR High School Diploma with 4+ years of relevant experience; AND 1+ year of previous GMP experience.
• Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials.
• Ability to analyze raw data and assess assay and system suitability criteria.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Good attention to detail and problem-solving skills.
• Good computer skills and ability to work under minimal supervision.
• Demonstrated written and oral communication skills.
• Demonstrated leadership skills.
• Strong organization and analytical skills.

Nice-to-haves

• Experience with microbiological testing in a laboratory setting.
• Familiarity with regulatory compliance in the biopharmaceutical industry.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling options