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Supply Chain Compliance Specialist 2
2 months ago
The Supply Chain Compliance Specialist 2 plays a critical role in ensuring the integrity of our supply chain operations at Fujifilm. This position is responsible for supporting all Supply Chain functions, procedures, systems, processes, and GXP-related matters in accordance with the Pharmaceutical Quality System. Key responsibilities include initiating and investigating internal and external exceptions impacting Supply Chain, supporting the establishment and implementation of comprehensive corrective and preventative actions to prevent recurrence and drive improvements, coordinating vendor change notifications, raw material enrollment, and supplier complaints.
Key Responsibilities- Creates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicable documentation to support the Supply Chain organization.
- Supports optimization projects to ensure continuous process improvements and development for the organization and/or client.
- Supports the analysis, revision, and resolution for master data issues, including inventory, SAP processes, cycle counting, and other processes within the Supply Chain function.
- Coordinates and leads change management records for raw material enrollment, vendor change notifications, and supplier complaints.
- Performs, initiates, and supports change management records, investigations, CAPAs, 3C, and CI activities for Drug Substance and Drug Product.
- Works in multiple functions and participates in projects/initiatives for Supply Chain support, including SAP, Warehouse, Shipping/Logistics, Master Data, Weigh and Dispense, and Raw Material Sampling.
- Leads investigations, updates SOPs, implements CAPAs, performs investigations, as needed.
- Collaborates with cross-functional teams and subject matter experts (SMEs) for assessment and necessary actions to meet schedules, compliance actions, or project initiatives.
- Plans, facilitates, and coordinates with SMEs, Quality, Manufacturing, Process Science, and Customers to ensure changes are implemented compliantly within defined timelines and documented in the appropriate quality system.
- Ensures data integrity and compliance for operations and audit readiness.
- High School or GED and 6 years of relevant work experience OR
- BS/BA degree in Supply Chain, Engineering, Information Science, Data Management, or Life Science related field and 2+ years relevant work experience
- BA plus 3+ years of relevant work experience
- SAP S4/HANA or other SAP ERP system experience
- GMP regulation experience
- Audits with FDA or similar organization management
- Advanced Excel skills
Fujifilm 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 identity, or any other protected class. If an accommodation to the application process is needed, please email.
