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. 

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.

Summary:  The Quality Assurance (QA) - Compliance Specialist I for Audit & Inspection will be responsible for  supporting all associated audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance, including  supporting client audits, regulatory inspections, and conducting internal and supplier audits.

Essential Functions:

• Leadership
• Work collaboratively with site management to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Compliance Delivery
• Support to the organization in conducting internal audits and hosting audits/inspections.
• New Business Growth
• Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
• Compliance
• Support the external and internal Audit Programs to be in an acceptable state of compliance.
• Responsible for audit preparations, conducting internal audits, and assisting client audits with site documentation gathering.
• Support Global Supplier Assurance - work with the global team to participate and represent Texas Site in supporting joint audits.
• Ensure no overdue training. Support other QA teams and other functions in completion of site actions.
• All other duties as assigned.

Required Skills & Abilities:

• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to set personal performance goals and provide input to departmental objectives.
• Ability to multitask and easily prioritize work.

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.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Lifting up to 25 pounds on occasion.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Must be willing to work flexible hours.
• Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory.

Minimum Qualifications:

• Bachelor’s degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
• Associate degree in a related science concentration with two (2) years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
• High School Diploma or GED with four (4) years of experience in Quality Assurance supporting pharmaceutical or biotechnology products.

Preferred Qualifications:

• Knowledge of GMP/GLP regulations
• Degree in Biology, Chemistry or Engineering

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 979-431-3500.