QC Microbiology Analyst III
Summary: The Microbiology Analyst III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
- 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 Biolog 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.
Required Skills & Abilities:
- 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.
Working Conditions & 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 on a computer.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to lift/pull/push 50 lbs on occasion and 15 lbs regularly.
- Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
- Attendance is mandatory.
- Master's degree preferably in Biochemistry, Chemistry, Biology or related field with two (2) years of relevant GMP experience; OR
- Associate of Science or Bachelor's degree preferably in Biochemistry, Chemistry, Biology or related field with three (3) years of relevant GMP experience; OR
- High School Diploma or GED with four (4) years of relevant GMP experience.
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 FDBTHR@fujifilm.com or call 979-431-3528.