Supply Chain Specialist 2, Compliance

Fujifilm•Holly Springs, NC

About The Position

The Supply Chain Compliance Specialist 2, is responsible for actions, processes, and audit readiness at FDBN. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements defined in the Pharmaceutical Quality System. Support includes initiation and investigation of 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. This role coordinates internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer requirements.

Requirements

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
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

Nice To Haves

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

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

Benefits

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions.
In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives.
We support life-work balance with paid vacation time, sick time, and company holidays.
Explore a supportive environment that enriches both your personal and professional growth!

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume