FUJIFILM Biotechnologies · 1 week ago
Supply Chain Specialist 2, Compliance
Holly Springs, NC
Full-time
Onsite
Entry, Mid Level
2+ years expFUJIFILM Biotechnologies is seeking a Supply Chain Compliance Specialist 2 to support all Supply Chain operations and ensure compliance with GXP requirements. The role involves creating and maintaining Standard Operating Procedures, coordinating change management records, and collaborating with cross-functional teams to drive process improvements and ensure audit readiness.
BiotechnologyHealth CareManufacturing
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
Performs other duties as assigned
Qualification
Required
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
Effective communication, both written and oral
Results-oriented and strong interpersonal skills
Effective problem-solving skills
Ability to effectively present information to others
Ability to work cross-functionally with a diverse team
Ability to prioritize with multiple priorities
Preferred
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
Benefits
Medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions
An industry leading 401(k) savings plan
Insurance coverage
Employee assistance programs
Various wellness incentives
Paid vacation time
Sick time
Company holidays
Company
FUJIFILM Biotechnologies
For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.
Founded in 2011Morrisville, North Carolina, USA
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Lars Petersen
President & Chief Executive Officer
Morten Munk
Director - Global Alliance Management
Recent News
Morningstar.com
2025-10-30
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