NCBiotech
Supply Chain Specialist 1, Compliance
NCBiotech, Holly Springs, North Carolina, United States, 27540
Supply Chain Specialist 1, Compliance
Job Locations: US-NC-Holly Springs
Posted Date: 3 weeks ago (12/8/2025 9:58 AM)
Position Overview 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.
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
Working Conditions & Physical Requirements PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes
Ability to sit for prolonged periods of time. No X Yes 60 minutes
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
EEO Statement We are an Equal Opportunity Employer. • Employees and applicants for employment are protected from discrimination on the basis of race, religion, color, creed, national origin, gender, pregnancy, handicap status, veteran status, sexual orientation, ethnicity, or any other manner in which anti-discrimination laws prohibit discrimination.
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Posted Date: 3 weeks ago (12/8/2025 9:58 AM)
Position Overview 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.
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
Working Conditions & Physical Requirements PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes
Ability to sit for prolonged periods of time. No X Yes 60 minutes
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
EEO Statement We are an Equal Opportunity Employer. • Employees and applicants for employment are protected from discrimination on the basis of race, religion, color, creed, national origin, gender, pregnancy, handicap status, veteran status, sexual orientation, ethnicity, or any other manner in which anti-discrimination laws prohibit discrimination.
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