Career Category

Job Description

This person assumes primary responsibility for execution of quality systems such as deviation process, procedures, change request, and corrective actions. Apply process operational scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support Louisville Distribution Center (LDC) Warehouse and Distribution Operations. The Specialist Supply Chain serves as a document owner, initiate, review, revise and approve deviations, change request and SOPs. The individual ensures all procedures reflect current operations and improves the quality and performance of the LDC Operations by identifying and implementing (continuous) improvements initiatives. The person provides support to warehouse operations Business Process Owners on related projects, non-conformances, triage activities, and business support activities.

Primary objectives:

• Work within full GMP compliance
• Own Deviations, CAPAs, CAPA-EVs and Change records
• Perform (comprehensive) Deviations and CAPA actions
• Generates Quality Records monthly metrics
• Lead Quality Records weekly meetings
• Generates change control records
• Effectively manage CAPA and Change implementation plans
• Ensure timely closure of owned records
• Develop, revise, and maintain operations related (GMP) documentation (SOPs and FORMs).
• Help to ensure integrity of available data
• Participate in continuous improvements initiatives
• Perform Risk-Based Decisions analyses as part of LDC risk management initiatives
• Become actively involved when required to resolve complex operational issues
• Participate in inspections audits from regulatory agencies and internal auditors
• Maintain compliant training records

Basic Qualifications:

• Doctorate degree  OR
• Master’s degree and 2 years of experience OR
• Bachelor’s degree and 4 years of experience OR
• Associate’s degree and 10 years of experience OR 
• High school diploma / GED and 12 years of experience 

Preferred Qualifications:

• Understanding of industry requirements (GMP, GDP)
• Ability to liaise/communicate effectively and easily with cross-functional teams and different cultures
• Proven troubleshooting, problem solving and investigational skills.
• Experienced with data diagnostics, discovery, modeling, and visualization (i.e., Tableau, Excel)
• Excellent written and oral communication skills
• Fluency in English, written and verbal
• Must be a team player that is willing lead, work in and embrace a team environment
• High personal integrity

Systems:

• Deviation/CAPA (TrackWise)
• CCMS
• CDOCS-Quality