LD Compliance Specialist III

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 trainees 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 importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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. InstructorLedCourses 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 FDBTs 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 FDBTs 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 multidisciplinary 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 handeye 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:

• Bachelors degree in Education Instructional Design Training Design or a related field and 3 years with training responsibility OR
• Bachelors 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 committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.