Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The Sr. Stability Technician monitors and analyzes data reports for accuracy and adverse trending identification as well as data compliance and consistency. Manages laboratory systems and other tools as required. In addition handles multiple priorities and delivers tasks/projects in a timely manner. Must comply with all security guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Reconcile data authorization and ensure it is done in compliance with stability procedures and maintain direct communication with personnel in charge of data authorization. By doing this, the Sr. Stability Technician will be a direct link between verifier and supervisor while optimizing the stability program. This will include all testing performed on the samples, considering communication with different areas like the Analytical and Microbiology Labs.
• Preparation of all required documentation for sample shipments to Out labs (Pre-shipments).
• Performing Stability Pulls and monthly reconciliation of future Stability Pulls with the preparation of reports within the program’s system.
• Generate reports for the stability data using electronic system and manual reports to comply with regulatory requirements and regional specifications.
• Organization of sample inventory and verification of all required documentation ensuring compliance with local procedures and regulatory requirements. This will include the handling of materials used within the stability program (samples in the long term storage (chambers), in process samples and reference standards use for testing).
• Perform “5S” audits and internal audits in the laboratory, recognizing areas for improvement and making sure the laboratory is in compliance in every moment.
• Documentation of required forms to retrieve equipment from the alarm reporting system, thus accelerating the process of the equipment repairs.
• Create studies within Sample Manager LIMS 11 system to support the stability requirement for annual commitment and validation activities.Reference Standard Receipt and documentation. Maintain logbook documentation organized and without discrepancies.
• Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required