Job Description

Location: Hybrid - Louisville, KY

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 11 months (possible extension)

Compensation: $35/$39 per hour (based on experience)

Summary of the Role

Join a large biotech pharmaceutical leader as a Sr Associate Supply Chain Compliance. This hybrid role manages temperature excursions, deviations, and CAPAs, supporting supply chain compliance across the US region. You will collaborate with global quality, supply chain, and external partners to ensure Good Distribution Practice (GDP) guidelines and continuous improvement initiatives are met.

Key Responsibilities

• Own and manage temperature excursion records for the US supply chain network
• Manage minor and major deviation records, leading root cause analysis sessions
• Own and implement CAPA and CAPA EV records
• Handle missing product notifications, including leading Event Review Team meetings
• Support audits and regulatory inspections
• Maintain up-to-date Smartsheets for deviations and missing product tracking
• Contribute to continuous improvement and GDP compliance initiatives
• Apply a risk-based approach and escalate issues appropriately
• Collaborate effectively with quality, IS, and external vendor organizations

Required Experience & Skills

• Bachelor’s degree or equivalent in Life Sciences with 2+ years of GMP/GDP compliance experience
• OR 4+ years of GMP/GDP compliance experience without a Life Sciences degree
• Strong knowledge of Quality Assurance, GMP, and GDP principles
• Proficiency with Smartsheet, Excel, PowerPoint, Trackwise/Trekwise, Veeva, and SAP
• Detail-oriented with strong multitasking and teamwork abilities
• Excellent communication and technical writing skills
• Fluency in English

Preferred Qualifications

• Experience supporting audits and inspections
• Technical writing expertise
• Prior experience in the pharmaceutical or biotechnology industry

Top 3 Must Have Skills

1. Bachelor’s degree or equivalent in Life Sciences plus 2 years’ GMP/GDP compliance experience

2. Strong knowledge of Quality Assurance, GMP, and GDP

3. Analytical and evidence-based problem solving

Day-to-Day Responsibilities

• Own and manage temperature excursion and deviation records
• Lead root cause analysis sessions and ensure CAPA implementation
• Maintain compliance tracking in Smartsheet
• Support and conduct audits and inspections
• Drive continuous improvement activities

Basic Qualifications

• High school/GED + 2 years work experience
• Associates and 6 months work experience
• Bachelors

This posting is for Contingent Worker, not an FTE