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

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