OTC Stability Specialist II

Added
9 days ago
Type
Full time
Salary
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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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