Stability Supervisor

Oversees the activities of the Stability Program. Assists management with the interpretation of Regulatory Guidelines for Stability testing. Determines stability sample requirements, develops stability protocols and oversees execution of stability protocols. Supervises and trains analysts. Interacts with internal and external auditors. Presents scientific information to management and regulatory agencies. Assists and facilitates when needed in special investigations. Recommends cost improvements & provides advice on routine QC operational procedures.

• Oversees the activities of the Stability Program such as preparation and execution of protocols and stability sample requirements.
• Stays current of and provides management with interpretation of Regulatory Guidelines for Stability testing.
• Responsible for ensuring that QC stability personnel are properly trained. Capable and available to step in and contribute to the training process when needed.
• Supervises the routine day-to-day testing by stability analysts and reviews analytical test results.
• Examines stability test data for consistency, identifies trends, and writes scientific reports.
• Prepares accurate data graphs per FDA guidelines to estimate product shelf-life for annual product reviews.
• Provides accurate stability summary reports to management and issues periodic stability reports on products.
• Assigns production batches for annual stability studies.
• Approves QC data packets as assigned by QC Management.
• Monitors the stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications.
• Provides QC management with technical advice; recommends cost improvements and provides advice on routine operational procedures as they pertain to stability testing.
• Ensures the stability lab is operating in compliance with current Good Manufacturing Practices (cGMPs) and current stability guidelines as they pertain to laboratory testing including, if needed, calibration of laboratory instruments.
• Writes and revises Standard Operating Procedures (SOPs) and stability specifications.
• Required to present scientific information to management, peers and subordinates, interact with auditors and be a spokesperson on behalf of the company.

Knowledge of equipment, supplies, components, technical areas that are utilized in the pharmaceutical industry, i.e.; High performance liquid chromatography, Gas chromatography, UV/VIS, FTIR, Spectrophotometers, disintegration, pH, viscosity, weighing equipment and controlled environment chambers.

Knowledge and experience in various aspects of the shelf-life of pharmaceutical products, knowledge of FDA guidelines on Stability requirements.

Requires computer skills, including knowledge of Microsoft Office suite (Word, Excel, Outlook) and Electronic Data systems.

Must have a full range of motor skills.

Must be flexible and able to handle multiple tasks.

Bachelor of Science degree in Chemistry or a closely related field or an equivalent combination of education and experience.

Three or more years of analytical chemistry experience in a quality control environment preferably in the pharmaceutical industry. Supervisory experience preferred.

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