- Responsible for the operation of Vanrx SA25 Vial Filling Isolator.
- Responsible for assisting in the formulation of the bulk drug product in accordance to procedures.
- Responsible for visual inspection and labeling of filled bulk drug product vials in accordance to procedures.
- Assist in writing, reviewing, and/or updating Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
- Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
- Help implement project safety and quality assurance programs in collaboration with senior staff and EH&S.
- Ensure proper documentation and execution of Batch Production Records for assigned projects.
- Maintain confidentiality of proprietary company information.
- Participate in incident investigations.
- Maintain an effective working relationship with others.
- Perform daily cleaning and sanitization on the laboratory.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Good oral and written communication skills as well as excellent interpersonal and organizational skills.
- Strong proficiency with Microsoft Office applications.
- Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required.
- Self-discipline and good attention to detail.
- Good math and computer skills.
- Must possess good planning skills and be willing to interface with colleagues in many different roles and functions throughout the manufacturing facilities and lead projects.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing environment.
- Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
- Attendance is mandatory.
- Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 1 year of relevant experience; OR
- Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 3 years of relevant experience; OR
- Associate’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 5 years of relevant experience; OR
- High School/GED with 7 years of relevant experience.
- Above experience must include one (1) year GXP experience.
- Experience in a GMP environment
- Biotechnology Certificate
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.