What are the responsibilities and job description for the Quality Systems Stability Specialist position at Renaissance Lakewood LLC?
- 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.
