Supply Chain Compliance Associate II

PURPOSE

The Supply Chain Compliance Associate in this role will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for Supply Chain. The Associate uses expert knowledge of cGMP regulations and project management to ensure error-proofing and compliance. The incumbent will also support documentation and operations improvement initiatives within Supply Chain. The Associate works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

ESSENTIAL JOB FUNCTIONS

• Utilizes Supply Chain knowledge and investigation skills to identify and resolve issues, improve process operations and affect positive change.
• Performs root cause analysis on Supply Chain quality events and leads investigations for minor and major quality events.
• Identifies and drives Supply Chain corrective and/or preventative actions.
• Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on change controls impacting Supply Chain.
• Participates on cross functional Vendor Change Notification team to drive material changes or improvements
• Participates in management of Supplier Corrective Action Requests
• Supports document revisions and/or document management including Standard Operating Procedures and Label Specifications.
• Supports Regulatory Agency inspections
• Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant documentation.
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance
• Creates and presents trending and metrics reports.
• Adaptability required as work schedule may change based on business needs
• Other duties as assigned

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting

Lifting

• Frequently lift and/or move up to 10 pounds • Occasionally lift and/or move up to 25 pounds Vision
• Frequently utilize close vision and the ability to adjust focus Communication • Frequently required to communicate by talking, hearing, using telephone and email

Vision 

• Frequently utilize close vision and the ability to adjust focus Communication

Communication

• Frequently required to communicate by talking, hearing, using telephone and email