Supply Chain Specialist , Compliance

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.

• 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

• 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

• High School or GED with 4 years of relevant work experience; OR
• Bachelor’s degree 0-1 years of experience

• Bachelor’s with 2 years of relevant work experience
• Experience with FDA Audits or similar organization management
• Experience with GMP regulations

• 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