Summary: 

The L&D Compliance Specialist III is responsible for the design, development, and delivery of training across the FDBT Organization. They must be able to think creatively when working with Subject Matter Experts across the organization to translate complex ideas into effective training that pertains to trainee’s role and performance. Additionally, they must be proactive in identifying training needs of individuals and departments, and ensure they are met.

The L&D Compliance Specialist III must be able to help overcome the challenges faced by internal stakeholders to produce and deliver training that efficiently develops trainee competence. This includes an ability to communicate when training should (or should not) be used as an intervention and to define measures for determining the desired performance gap has been closed.

If required, the L&D Compliance Specialist III supports the defense of FDBT Learning and Development program in Customer audits. Using their knowledge of regulations and Adult Learning principles to highlight the suitability of the program to develop competent staff.

An ability to prioritize and plan is essential to ensure training obligations (such as new hire training) and other duties are met. Additionally, the L&D Compliance Specialist III evaluates training methodologies and training effectiveness is required to ensure business and regulatory expectations are met.

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

Essential Functions:

• Applies Adult Learning and Instructional Design principles to assure trainee competency and meet learning needs.
• Create, revise, and review Training Materials (i.e. Instructor-Led-Courses and Critical Activity Qualifications).
• Create, revise, and review Computer Based Training (CBT) using tools such as Articulate.
• Supports Job Task Analysis (JTA) and Training Needs Analysis (TNA) as required, updating appropriate training plans.
• Designs and maintains ComplianceWire curricula across the organization.
• Designs and implements L&D processes and tools such as Training Rubrics.
• Scheduling and delivery of key training (such as New Hire Quality training).
• Write and revise procedural instruction as required.
• Work with eQMS and internal stakeholders to maintain FDBT’s Learning Management System.
• Support Internal, Customer and Regulatory audits by providing training reports as required.
• Support the defense of FDBT Training in Customer Audit as required.
• Actively participate and promote FDBT’s Proactive Safety Program.
• Work in Trackwise system to address Training related Deviations and ensure the timely completion of Training CAPAs (as required).
• Facilitate the delivery of Training for Trainers Parts I and II.
• Evaluate prospective Trainers as part of the FDBT Training for Trainers Program.
• Assist trainees and trainers in the scheduling of training as needed.
• Independently complete Administrative Training Tasks (i.e. Access Forms) in a timely manner.
• All other duties as required.

Required Skills & Abilities:

• Demonstrates a good understanding of current Good Manufacturing Practice requirements and regulation.
• Strong communicator who actively listens and can convey information clearly in written and verbal formats.
• Create actionable goals and objectives for trainees.
• Strong facilitator in a training session: engaging trainees and using questioning to effectively confirm understanding and knowledge.
• Applies Adult Learning principles and Instructional Design principles to FDBT training.
• Root Cause Analysis.
• Lead complex small scale training projects to a successful conclusion.
• Identify and prioritize learning needs.
• Evaluate training effectiveness to an appropriate level.
• Able to successfully work alone or as part of a multi-disciplinary team to meet deadlines.
• Proficient in Microsoft Excel, Word, and Powerpoint.

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.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory.

Qualifications:

• Bachelor’s degree in Education, Instructional Design, Training Design or a related field and 3+ years with training responsibility OR
• Bachelor’s degree in Biotechnology or related field and 5+ years with training responsibility.

Preferred Qualifications:

• Experience in a cGMP or other regulated environment.
• Certification relating to Training
• ASQ Certification or similar

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).