Biosafety Specialist II
College Station, Texas
- Assist the Biosafety Officer with coordination and implementation of the FDBT Biosafety Program.
- Provide professional guidance and administrative support to the laboratory and manufacturing staff.
- Assist with coordination of documentation for review of client projects for hazard identification, risk mitigation, biosafety level, and compliance with NIH Guidelines.
- Plan, schedule, coordinate activities of the Biological Risk Assessment Team (BRAT) and act as liaison between BRAT and Program Management.
- Perform IBC administrative support functions, including interpretation of guidelines and responding to inquiries, preparing correspondence and reports, logistical set up of meetings; recommend policies, procedures and standard operating guidelines that facilitate compliance.
- Development and implementation of a post-approval project and facility audit process.
- Development and delivery of related training in a variety of formats.
- Assist with management of regulated medical waste.
- Provide additional assistance with a variety of EHS functions as delegated by the EHS Manager.
- Perform other duties as assigned
Required Skills and Abilities:
- Knowledge of best biosafety practices according to federal and international guidelines and basic knowledge of guidance and regulations affecting activities with recombinant DNA
- Ability to work independently and to interpret policies and procedures to solve unusual and/or difficult problems;
- Excellent organizational skills;
- Proficient with Microsoft Office Tools (e.g. Word, Excel, PowerPoint);
- Experience developing and maintaining computerized databases and tracking systems;
- Excellent interpersonal, written and verbal communication skills with the ability to work cross functionally
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 sitting, standing, walking, bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate portable tools, test instruments, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
- Wear appropriate PPE.
- The ability to regularly lift and/or move up to 50 pounds.
- Climb ladders and stairs of various heights.
- Be exposed to wet or humid conditions.
- This position may be On-Call for emergencies.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory.
- Associate’s Degree, preferably in life science, with five (5) years of full time experience in Biosafety; OR
- Bachelor’s Degree with three (3) years of full time experience in Biosafety, preferably in a research, teaching, or laboratory setting.
- Experience with Google Business Enterprise applications (Drive, Docs, Sheets, Slides, Sites, Keep, etc.)
- Experience developing and maintaining SharePoint site
- Knowledge of federal regulations and guidelines relating to the use of biological agents;
- Experience creating classroom and online training presentations, and teaching/training various size groups.
- Knowledge of Division 6.2 federal and international shipping regulations.
- Knowledge of import/export permitting regulations for biological materials (CDC, USDA, FWS, FDA, etc.)
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 e-mail FDBTHR@fujifilm.com or call 979-431-3528.