Overview

The Compliance Training Specialist will be responsible for supporting the Manufacturing Operations Organization around GMP compliance, unit operation and equipment training, as well as coordination of batch disposition with Quality Assurance.

This position will focus on ensuring programs can be dispositioned successfully and on time by coordinating and reviewing executed records and partnering with Quality to address issues. Individuals in this role will lead continuous improvement initiatives focused on GMP compliance, safety compliance, manufacturing efficiency and cost-savings. They will author, collaborate, or own deviations related to Manufacturing Operations execution, as well as support, own, or collaborate on CAPAs, change controls, SOPs, Work Instructions and other procedures related to Manufacturing Operations execution.

This position will also design, deliver and monitor the effectiveness of unit operation and equipment training for new Technician on-boarding, Technician cross-training or continuous Technician development. The individual in this role must be able to recognize and address areas where training opportunities exist in order to achieve safe, compliant and Right First Time execution.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Provide In-the-moment coaching of Manufacturing Technicians on GMP Operations and Documentation Practices

• Support right-first-time execution for Manufacturing Operations through championing programs devised through collaborating with Manufacturing Leadership, MT&S, Manufacturing Specialists, and Production Managers.
• Support timely release and disposition of batches through collaboration on disposition-related tasks where required.
• Support the evaluation of training courses for effectiveness using trainee feedback, area management discussions, deviation reports, etc. as sources of information and to recommend improvements.
• Support administration of Technician Training program; including continuous improvement of the training program.
• Author, collaborate or own deviations related to Manufacturing Operations execution.
• Support continuing development and designs, delivers or arranges training to meet the needs of existing Technicians, newly onboarded Technicians and/or Cross-Training Technicians.
• Support by providing training to trainers by evaluating the trainers’ ability to perform the task and assessing effectiveness to train technicians.
• Interaction with groups such as Materials Management, EHS, Quality Control and Quality Assurance (QA) on any issues that may arise during the shift, record review or training.

BACKGROUND REQUIREMENTS:

• BS/BA (science preferred) and 3 years of experience in a cGMP (pharmaceutical/manufacturing environment or
• AA (science preferred) and 5 years of experience in a cGMP (pharmaceutical/manufacturing) environment or 7 years of experience in a cGMP (pharmaceutical/manufacturing) environment
• SME within one area on the Manufacturing Production Floor.

Desired Skills:

• Prior experience and/or demonstrated aptitude to delivering effective training in a cGMP manufacturing environment, including task/practical training for operations.
• Prior experience coaching in a cGMP environment with experience in GMP Operations and documentation practices
• Proficiency of Microsoft skills and applications 

Working Location:

This is an on-site position; working-from-home on occasion by arrangement. This position supports staff working seven days per week and 24 hours per day, and a minimum of 25% of the role will require in-person hands-on task and unit operation training on night shift (to be delivered between 7pm and 7am). Individuals must be available to consult via phone, zoom, and in person, when needed.

Physical Demands:

This positiondemands certain physical capabilities that are essential for successful performance frequently throughout the shift (up to 12 hours), including but not limited to climbing ladders or stairs, standing, pushing, pulling, stooping, reaching, bending, and typing. The physical effort and lifting involved with this role can vary ranging from sedentary tasks up to medium-level exertion up to 50 pounds.

As part of the regular responsibilities of this job, candidates should be prepared to work occasional weekends and nights, as per the assigned shift schedule designated by the manager.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.