QC Analyst III, Microbiology

The QC Analyst III, Microbiology will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Diosynth Biotechnologies Texas (FDBT) Quality Control Laboratory.

Reports to Associate Director, QC Contamination and Control and QC Manager, Microbiology

Work Location College Station, TX

Primary Responsibilities:

• Responsible for QC microbiological aspects of cGMP compliance and testing.
• Perform microbiological verifications as needed for finished product and in process controls and buffers.
• Qualification of microbiological media, diluents, and organisms.
• Qualification of APS media and inspection for turbidity.
• Biological Indicator Testing and qualification activities.
• Material Bioburden Testing and Bioburden Suitability.
• Bacterial Endotoxin Testing and Inhibition/Enhancement Testing for Product Samples and Buffers.
• Bacterial Identifications using the Biology and Fungal Identifications by the Macroscopic Identification method.
• Sub-Visible particulate Testing by USP <787>, <788> and <789>, Method 1 and Method 2.
• Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
• Participate in the investigation of microbiological data deviations and PRs.
• Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation.
• Review of EM and product release data.
• Ensure lab is maintained (organized, clean, properly supplied).
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree preferably in Biochemistry, Chemistry, Biology, or related field with 2+ years of relevant experience; OR
• Associate of Science preferably in Biochemistry, Chemistry, Biology, or related field with 3+ years of relevant experience; OR
• High School Diploma or 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, assess assay and system suitability criteria.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Good attention to detail and ability to utilize problem solving/trouble shooting skills.
• Good computer skills.
• Work under minimal supervision.
• Demonstrated written and oral communication skills.
• Demonstrated leadership skills.
• Strong organization and analytical skills.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email [email protected] or call 979-431-3528.