Job Description

Location: Hybrid - Louisville, KY

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $26/$30 per hour (based on experience)

of the Role

As a Senior Associate in Supply Chain Compliance for a large biopharma leader, you will oversee temperature excursions, deviation management, CAPA records, and supply chain quality continuous improvement projects. This role centers on maintaining high standards in Good Distribution Practices (GDP) and collaborating with multiple internal and external stakeholders. You will be responsible for compliance within the US Supply Chain network and will support audits, inspections, and quality initiatives.

Key Responsibilities

• Own and manage temperature excursion records for the supply chain.
• Handle minor and major deviation records; lead root cause analysis sessions.
• Oversee CAPA and CAPA EV records, ensuring proper implementation.
• Manage missing product notifications and lead Event Review Team meetings as needed.
• Support audits and inspections related to supply chain compliance.
• Maintain up-to-date Smartsheets for deviations, CTETS, missing products, and continuous compliance.
• Lead or support continuous improvement initiatives within the supply chain.
• Apply a risk-based approach to decision-making and escalation.

Required Experience & Skills

• Bachelor’s degree or equivalent in Life Sciences and at least 2 years’ experience in GMP / GDP compliance, or 4+ years’ experience in GMP / GDP compliance without a Life Sciences degree
• Sound knowledge of Quality Assurance principles, GMP, and GDP
• Analytical, evidence-based approach to problem solving
• Technical writing and strong experience with Smartsheet, Excel, PowerPoint, and Trackwise/Trek wise
• Fluency in English
• Strong word processing, database, and spreadsheet application skills
• Local to Louisville, KY, or able to commute onsite 3 days per week

Preferred Qualifications

• Experience supporting audits or inspections
• Familiarity with Veeva and SAP
• Background in laboratory or pharmaceutical quality
• Proven detail orientation and multitasking
• Teamwork and effective cross-functional communication

Top 3 Must Have Skills

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

2. Strong knowledge of Quality Assurance, GMP, GDP

3. Analytical and evidence-based problem-solving

Day-to-Day Responsibilities

• Manage compliance records including temperature excursions, deviations, CAPA/CAPA EVs, and missing products
• Lead root cause analysis and continuous improvement projects
• Support regulatory audits and ensure compliance documentation is current
• Collaborate with quality, IS, and external vendors to drive GDP standards

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