Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization that delivers a diverse portfolio of medicines essential to patients worldwide
Job Summary
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization that delivers a diverse portfolio of medicines essential to patients worldwide.
The QA Associate position is essential for ensuring all batches meet specifications, comply with validated processes, and regulatory commitments while providing on-site support during manufacturing events and inspections.
Lilly is dedicated to helping individuals with disabilities actively engage in the workforce and ensures equal opportunities during the application process.
Matching Summary
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization that delivers a diverse portfolio of medicines essential to patients worldwide.
Skills & Requirements
Must-have
GMP manufacturing experience in API
Quality oversight of contract manufacturers
Regulatory inspection preparation
Batch release and documentation review
cGMP compliance and quality control
Process validation and technical transfer
English fluency
Nice-to-have
Coaching and mentoring skills
Root cause analysis experience
Statistical skills application
Strong written and verbal communication
Attention to detail
Interpersonal and networking skills
Ability to prioritize multiple tasks
Influence and relationship management
Key Requirements
BS in Pharmacy, Chemistry or Life Sciences
Minimum 5 years GMP QA floor support experience
Minimum 10 years QA experience in big pharma
Foundational knowledge of ICH and EMA regulations
Experience with internal and regulatory inspections
Process validation and technical transfer experience