QA Stability Specialist II Job

A a QA Stability Specialist II is needed to perform the following duties:

· · Coordinate and manage stability studies for drug products and drug substances in compliance with regulatory guidelines (ICH Q1A, FDA, WHO, etc.).

· Author, review, and approve stability protocols, summary reports, and deviations.

· Ensure accurate and timely data entry into stability databases and ensure data integrity.

· Review stability data for trends and out-of-trend (OOT) or out-of-specification (OOS) results.

· Support investigations and CAPAs related to stability issues.

· Maintain stability chambers, ensuring qualification, calibration, and compliance with environmental monitoring requirements.

· Participate in internal and external audits and provide documentation as required.

· Collaborate with cross-functional teams including Analytical Development, Manufacturing, Regulatory Affairs, and Quality Control.

· Support regulatory submissions by providing stability data and documentation (NDA, ANDA, IND, etc.).

· Ensure compliance with cGMP, GDP, and all applicable regulatory requirements.

Bachelor's Degree in Regulatory Affairs or Pharmaceutical Sciences or Pharmaceutics

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave