Position Overview

The Supply Chain Specialist 3, Compliance is responsible for 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. The SC Specialist 3, Compliance initiates and
investigates internal and external exceptions impacting Supply Chain. This role leads the implementation of comprehensive corrective and preventative
actions (CAPA) to drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinates
and is responsible for leading internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer
requirements. The SC Specialist, Compliance will be coordinating change management record (CMR) for new raw material enrollment, supplier complaints
and vendor change notifications.

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
• Leads optimization projects to ensure continuous process improvements and development for the organization and/or client
• Manages the analysis, revision, and resolution for master data issues, including inventory, SAP processes, cycle counting and other processes within
the Supply Chain function
• Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs), and continuous
improvement activities for Drug Substance and Drug Product
• Leads complex investigations when needed and drives actions through cross functional team
• Engages in teams to update SOPs, implement CAPAs, perform investigations and lead these, as needed
• Creates or revises SOPs and/or Work Instructions to support all Supply Chain Operations and functions
• Leads and supports implementation and maintaining the Vendor Change Notification, Supplier Complaint, and Material Enrollment processes
• Coordinates and leads teams within multiple functions and participate in projects/initiatives for Supply Chain support (e.g., SAP, Warehouse,
Shipping/Logistics, Master Data, Weigh Dispense and Raw Material Sampling)
• Collaborates with cross functional teams and subject matter experts (SMEs) for assessment and necessary actions to meet schedules, compliance
actions, or project initiatives
• Ensures data integrity and compliance for operations and audit readiness
• Performs other duties, as assigned

Basic Requirements
• High School or GED and 9+ years of relevant work experience, or
• Bachelor's degree in Supply Chain, Engineering, Information Science,
Data Management, or Life Science related field with 5+ years
relevant work experience

Preferred Requirements
• Master's degree in Supply Chain, Engineering, Information Science,
Data Management, or Life Science related field with 3+ years of
relevant work experience
• Experience in quality management systems (e.g., SAP S4/HANA,
Trackwise, Veeva)
• Experience with GMP regulations, audits with FDA or similar
organization management

WORKING CONDITIONS & 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. X No 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. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to conduct activities using repetitive motions that include writs, 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