Qa Specialist, Stability

Perform laboratory support functions such as sample log-in and storage, issuance of controlled data forms, and monitoring of temperature controlled chambers in compliance with standard operating procedures, safety, and cGMP regulations. Responsible for all associated documentation and for maintenance of stability storage area. laboratory area.

• Thorough understanding and compliance with FDA cGMPs / cGLPs / USP / ICH / SOPs
• Manage cGMP system for incoming and outgoing samples. Receive and log in samples as per SOP. Maintain inventory and chain of custody.
• Manage cGMP system for stability samples. Follow protocols, stage, and load samples, manage pull schedules. Sets-up Stability Studies, including labeling and placement of samples into the appropriate environmental chamber. Pull and submit samples as per approved protocols and SOP. Maintain inventory and chain of custody.
• Ship samples as required by approved protocols and client requests. Review data from temperature monitoring devices as appropriate. Investigate and resolve any excursions or other deviations.
• Responsible for the daily monitoring of Stability Chambers
• Able to react to change productively and handle other essential tasks as assigned.
• Issues and/or reviews Stability Trending Reports
• Reviews and approves Stability Summary Reports
• TrackWise Deviation
• Order Tracking
• Ensures compliance with internal procedures and regulatory guidance within the Stability group.
• Controlled substances handling including maintaining inventory, paperwork, biannual review.
• Perform other related duties as may be reasonably assigned in the course of business.

Associate Degree in Chemistry or related science discipline required with at least 1 year of pharmaceutical industry relevant experience or equivalent.
Bachelor’s degree (BA/BS) in Chemistry or related science discipline preferred.