Stability Specialist

Key Responsibilities

• Review stability study data, reports, and supporting documentation for accuracy, completeness, and regulatory compliance.
• Provide technical feedback and recommendations to CROs regarding stability reports and study outcomes.
• Collaborate with internal stakeholders and external partners to support ongoing stability programs.
• Ensure stability documentation is maintained in accordance with company procedures and regulatory requirements.
• Utilize Veeva systems for document management, review workflows, and record maintenance.
• Support investigations, trend analysis, and assessment of stability-related issues as needed.
• Participate in cross-functional discussions regarding product stability strategies and findings.
• Communicate stability concepts and data effectively to both technical and non-technical stakeholders.

Required Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline.
• 2-5 years of pharmaceutical industry experience.
• Demonstrated experience supporting or managing stability programs.
• Working knowledge of ICH stability guidelines and pharmaceutical product stability requirements.
• Experience reviewing technical reports and providing feedback to external partners or CROs.
• Hands-on experience with Veeva systems.
• Strong analytical, technical writing, and communication skills.
• Ability to work independently in a remote environment.

Preferred Qualifications

• Experience working with CDMOs and external manufacturing or testing partners.
• Familiarity with quality systems, regulatory documentation, and GMP environments.
• Experience supporting commercial or late-stage development products.