Quality Assurance Specialist

Supply Chain Sr. Associate
- Quality Assurance

Location:

Hybrid
- Louisville, KY

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

Join a large biotech pharmaceutical leader as a Supply Chain Sr. Associate supporting Good Distribution Practice compliance across the U.S. Supply Chain network.

This role will own and manage quality records, deviations, temperature excursions, CAPA activities, and missing product notifications while partnering with Quality, Supply Chain, IS, and other internal and external stakeholders.

This hybrid position requires 3 days onsite in Louisville, KY and is ideal for someone with strong GMP/GDP compliance knowledge, technical writing skills, quality systems experience, and an analytical approach to problem solving.

• Embed Good Distribution Practices across the U.S. Supply Chain network to help maintain product quality
• Own and manage temperature excursion records
• Lead root cause analysis sessions for minor and major deviations
• Own and manage CAPA and CAPA EV records, ensuring proper documentation and effective implementation
• Manage missing product notifications and lead Event Review Team meetings when required
• Support audits, inspections, and compliance readiness activities
• Maintain accurate and up-to-date Smartsheets for deviations, CTETS, and missing products
• Contribute to continuous improvement initiatives across supply chain compliance processes
• Apply a risk-based approach to decision-making, issue escalation, and compliance activities
• Collaborate cross-functionally with Quality, Supply Chain, IS, and business stakeholders

• 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 principles, GMP, and GDP
• Experience managing deviations, temperature excursions, CAPAs, or quality records
• Analytical and evidence-based approach to problem solving
• Strong technical writing skills
• Experience using Smartsheet, Excel, PowerPoint, and Track Wise
• Experience with Quality Management Software systems such as Track Wise or EDMQ
• Strong communication skills and ability to work cross-functionally
• Detail-oriented, disciplined, and collaborative working style
• Ability to support compliance activities in a hybrid environment with regular onsite presence

• Experience supporting audits and inspections
• Knowledge of Veeva and SAP
• Previous pharmaceutical industry experience
• Strong technical writing background

• Bachelor’s degree or equivalent in Life Sciences with 2+ years of GMP/GDP compliance experience
• Strong knowledge of Quality Assurance principles, GMP, and GDP
• Analytical and evidence-based problem-solving skills

• Own and manage temperature excursion and deviation records
• Lead root cause analysis sessions and support issue resolution
• Ensure CAPA and CAPA EV records are properly documented and implemented
• Support audits, inspections, and compliance documentation
• Maintain compliance trackers, Smartsheets, and quality records
• Collaborate with Quality, Supply Chain, IS, and other stakeholders
• Manage missing product notifications and lead review meetings as needed
• Support continuous improvement initiatives and apply risk-based decision-making

• High school diploma / GED and 2 years of work experience, OR
• Associate’s degree and 6 months of work experience, OR

Ready to support GDP compliance, quality records, and supply chain operations for a global biotech organization?

This is a W2 contract opportunity only. No C2C, 1099, or third-party vendor submissions. Candidates must be authorized to work in the United States without current or future sponsorship.