FUJIFILM Biotechnologies
Supply Chain Specialist 1, Compliance
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
The Supply Chain Specialist 1, Compliance is responsible for supporting actions, processes, and audit readiness. 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. The SC Specialist 1, Compliance assists with initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of comprehensive corrective and preventative actions (CAPAs) 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.
Job Description What You’ll Do
Creates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicable documentation to support the Supply Chain organization
Supports and coordinates supplier change notification (SCN) activities, logging the SCN in the tracker, coordinating review with subject matter expert (SME), while opening and owning change management records, as needed
Participates in optimization projects to ensure continuous process improvements and development for the organization and/or client
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 improvement, and continuous improvement (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
Coordinates 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
Other duties, as assigned
Knowledge & Skills
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 manage with multiple priorities
Advanced Excel skills
Basic Requirements
High School or GED with 4 years of relevant work experience; OR
Bachelor’s degree 0-1 years of experience
Preferred Requirements
Bachelor’s with 2 years of relevant work experience
Experience with FDA Audits or similar organization management
Experience with GMP regulations
Physical Requirements
Work in environments that may necessitate respiratory protection
Work in mechanical/production spaces that may require hearing protection and enrollment in a hearing conservation program
Work in environments operating a motor vehicle or Powered Industrial Truck
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time (up to 60 minutes)
Ability to sit for prolonged periods of time (up to 60 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
Ability to operate machinery and/or power tools
Ability to conduct work that includes moving objects up to 10-33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions
Work in warm/cold environments (approximate temperature ranges unspecified)
Work in outdoor elements such as precipitation and wind
Work in small and/or enclosed spaces
Work in heights greater than 4 feet
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Job Description What You’ll Do
Creates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicable documentation to support the Supply Chain organization
Supports and coordinates supplier change notification (SCN) activities, logging the SCN in the tracker, coordinating review with subject matter expert (SME), while opening and owning change management records, as needed
Participates in optimization projects to ensure continuous process improvements and development for the organization and/or client
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 improvement, and continuous improvement (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
Coordinates 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
Other duties, as assigned
Knowledge & Skills
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 manage with multiple priorities
Advanced Excel skills
Basic Requirements
High School or GED with 4 years of relevant work experience; OR
Bachelor’s degree 0-1 years of experience
Preferred Requirements
Bachelor’s with 2 years of relevant work experience
Experience with FDA Audits or similar organization management
Experience with GMP regulations
Physical Requirements
Work in environments that may necessitate respiratory protection
Work in mechanical/production spaces that may require hearing protection and enrollment in a hearing conservation program
Work in environments operating a motor vehicle or Powered Industrial Truck
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time (up to 60 minutes)
Ability to sit for prolonged periods of time (up to 60 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
Ability to operate machinery and/or power tools
Ability to conduct work that includes moving objects up to 10-33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions
Work in warm/cold environments (approximate temperature ranges unspecified)
Work in outdoor elements such as precipitation and wind
Work in small and/or enclosed spaces
Work in heights greater than 4 feet
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