Location:Hybrid - Louisville, KY
Employment Type: Contingent Worker (Contract, W2)
Contract Length: 12 months (possible extension)
Compensation: $26/$30 per hour (based on experience)
Summary of the Role
Join a big biopharma leader as a Sr Associate Supply Chain Compliance, supporting Good Distribution Practice (GDP) compliance across US supply chains. You will own and manage quality records, deviations, temperature excursions, and CAPA processes, collaborating with quality, supply chain, and IS teams. This position is hybrid with 3 days onsite and regular interaction with various internal and external stakeholders.
Key Responsibilities
- Embed Good Distribution Practices in the US Supply Chain network to 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 effective implementation
- Manage missing product notifications and lead Event Review Team meetings when required
- Support audits and inspections
- Maintain up-to-date Smartsheets for deviations, CTETS, and missing products
- Contribute to and support continuous improvement initiatives
- Apply a risk-based approach to decision making and issue escalation
Required Experience & Skills
- Bachelor’s degree or equivalent in Life Sciences with 2+ years of experience in GMP/GDP compliance OR 4+ years of experience in GMP/GDP compliance without a Life Sciences degree
- Sound knowledge of Quality Assurance, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP)
- Analytical and evidence-based approach to problem solving
- Technical writing proficiency with Smartsheet, Excel, PowerPoint, and TrackWise
- Experience with Quality Management Software systems (e.g., TrackWise, EDMQ)
- Strong communication skills and ability to work cross-functionally
- Detail-oriented, disciplined, and effective collaborator
Preferred Qualifications
- Experience in audit and inspection support
- Knowledge of Veeva and SAP
- Previous pharmaceutical industry experience
- Technical writing skills
Top 3 Must Have Skills
1. Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP/GDP compliance
2. Sound knowledge of Quality Assurance principles, GMP, and GDP
3. Analytical and evidence-based problem-solving skills
Day-to-Day Responsibilities
- Own and manage temperature excursion and deviation records
- Lead root cause analysis and ensure CAPA records are properly documented and implemented
- Support audits, maintain compliance records, and drive continuous improvement initiatives
- Collaborate on missing product management and lead review meetings as needed
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