Related skills
gmp capa cgmp analytical method development stability📋 Description
- Work with R&D and PM to plan stability studies and set expiration dates.
- Confirm data supports assigned expiration; maintain SLED reflecting stability data.
- Monitor stability processes; GMP for chambers; update SOPs; manage excursions and CAPAs.
- Facilitate analytical method development and method transfer validation; SME for formulation changes.
- Develop protocols, request samples, label and place them in stability chambers; track results.
- Maintain stability data and investigations; circulate reports for management review; lead CAPAs.
🎯 Requirements
- Bachelor’s degree in Chemistry, Microbiology, or related disciplines.
- 5+ years Quality or Analytical Laboratory experience.
- 5+ years applying cGMP concepts.
- 3+ years stability study coordination or execution experience.
🎁 Benefits
- Healthcare and 401(k) with company match on day one.
- 36 total days off (vacation, holidays, sick).
- Opportunities for ongoing development and skill growth.
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