Material Reconciliation Team Lead
Overview:
Working as part of FUJIFILM Diosynth Materials Reconciliation Group, the Team Lead position provides business direction for two temporary employees, while concurrently focusing on ensuring material genealogy is accurate and timely. Two separate cGMP systems are used in this process and the role of the Materials Reconciliation Specialist is to look for discrepancies, investigate root cause of any differences, make the corrections required, and track/trend data to define long-term mitigations.
To be considered for this role, qualified candidates must have the requisite years of experience working directly with Materials Requirement Planning (MRP), Enterprise Resource Planning (ERP), and with auditing paper records used in biopharmaceutical manufacturing.Candidate must have demonstrated experience with leadership, cGMP practices, making corrections in a compliant manner, with an understanding of materials workflow and warehouse management. The ideal candidate will be meticulous, process-driven and have first-class attention to detail.
Experience with database management and process definition is a plus.
This role is onsite, full-time at FUJIFILM’s campus in Research Triangle Park, North Carolina.
External US:
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Taking direction from the Head of Transformation, the job holder will:
- - Oversee performance and provide business direction to two Materials Reconciliation Specialists
- Audit paper batch records to ensure genealogy is accurately reflected in FUJIFILM’s digital systems
- Upon discovery of any discrepancies, the job holder will investigate and define root cause
- Determine steps necessary to correct each discrepancy and the value/cost of each
- Make any required corrections in SAP and/or PAS-X system to ensure accurate/timely consumption and genealogy
- All corrections must be documented and tracked to define future Transformation projects to eliminate any sources of variation. The Materials Reconciliation Team Lead will provide weekly and monthly reports on progress, data trends, and total value of all corrections made.
- This role and the associated responsibilities will develop as the project matures and data is collected.
- Performs other duties as assigned.
COMPETENCIES
Thoroughness- Takes action to tie up loose ends
- Checks to ensure data is accurate and sustainable
- Makes sure all necessary corrections and tasks have been completed
- Refers others to source data when debating contentious issues
- Focuses on the problem rather than the person in a debate
- Actively seeks ways of improving current methods, systems, processes and structures
- Evaluates opportunities to use time and resources more cost effectively
- Points out redundant or unnecessary steps in methods or procedures
- Explicitly understands the consequences of not maintaining the highest level of standard, particularly related to cGMP practices and inspection readiness
- Works to meet standards of excellence
- Takes action to ensure consistent application of procedures/systems.
- As appropriate, write and or revise SOPs/business practices/work instructions
- Takes responsibility for the consequences of their actions and openly admits mistakes and takes actions to correct situations/change behaviors
- Demonstrates willingness to share responsibility with others in the group to advance the team's progress as needed
- Objectively considers others' ideas, opinions, and looks for opportunities for improving the work
- Seeks feedback and opportunities to grow
- Reviews work to ensure accuracy, completeness, and quality
- Mentors team members with the goal of achieving employee empowerment
- Assists the team with the development of objectives and ensures alignment with site and department goals.
- Serves as liaison between Material Reconciliation team and other departments
BACKGROUND REQUIREMENTS:
Minimum Qualifications- B.S. /B.A. degree preferred (science, business, or engineering preferred) OR Equivalent Military training or experience
- Knowledge and awareness of cGMP documentation practices
- 2+ years’ experience working with MES and/or ERP systems (or equivalent database management or administration)
- Experience working within a Biotech/Pharma Organization or Contract Development and Manufacturing Organization
- Previous Team Lead or direct line management experience is a plus
- Prior experience and basic understanding of cell culture, upstream processes, recovery and/or downstream processes
- Experience working directly with PAS-X, SAP Hana, or other MES/ERP systems
- Yellow belt certification or equivalent experience in the application of lean and six sigma tools and methodologies
- Evidence of other continued professional development
The ideal candidate will have the following knowledge, skills and aptitude:
- Works effectively independently and as part of a team
- Excellent written and verbal communication skills
- Strong computer skills with proficiency in using Microsoft Office Suite (MS Word, Excel, PowerPoint, etc.) for data gathering, data entry, and reporting.
- Ability to present complex information in a clear and concise manner
- Goal-oriented, flexible, and able to manage multiple priorities.
- Must have good planning skills and must be willing to interface colleagues across all levels of the organization.
- Ability to discern audible cues
- Ability to stand for prolonged periods of time
- Ability to sit for prolonged periods of time
- Ability to conduct work that includes moving objects up to 10 pounds
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.