QC Analyst III, Microbiology

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki. 

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

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.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work