Stability Supervisor

Stability SupervisorJob Summary:Oversee the activities of the Stability Program. Assist management with the interpretation of Regulatory Guidelines for Stability testing.  Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols.  Supervise and train analysts. Write SOPs and revise stability specifications, review analytical test results, examine stability test data for consistency, identify trends, write scientific reports, prepare stability data graphs to estimate expiration dates and verify product shelf life, filing and archiving stability studies.  Insure that the stability lab is operating in compliance with cGMP as they pertain to laboratory testing, including, if needed, calibration of laboratory instruments.  Interact with internal and external auditors. Present scientific information to management and regulatory agencies. Assist and facilitate when needed in special investigations. Recommend cost improvements and provide advice on routine operational procedures as they pertain to stability testing. Essential Functions:Oversee the activities of the Stability Program (e.g. preparation & execution of protocols, etc). § Stay current and provide management with interpretation of Regulatory Guidelines for stability testing.§ Supervise the routine day-to-day testing by stability analysts and review analytical test results.§ Review stability test data for consistency, identify trends, and write scientific reports.§ Provide accurate stability summary reports to management and issue periodic stability reports on products. § Assign production batches for annual stability studies. § Approve QC data packets as assigned by QC Management.§ Monitor the Stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications.§ Provide QC management with technical advice; recommend cost improvements and provide advice on routine operational procedures as they pertain to stability testing.§ Insure that the stability lab is operating in compliance with current good manufacturing practices and current stability guidelines as they pertain to stability studies and laboratory testing, including, if needed, calibration of laboratory instruments.§ Write and revise SOPs.§ The supervisor is required to interact with auditors and be a spokesperson on behalf of the Company.§ The jobholder is responsible for insuring that QC stability personnel are properly trained; must be available to step in and contribute to the training process when needed.§ Oversee and maintain the stability tracking database and sample management.§ Present scientific information to management, peers and subordinates. Additional Responsibilities:§ Carry out informal test failure investigations and write Deviation Reports. § Supervise method validation and transfer from AMD to the QC Lab.§ Evaluate stability data to develop stability specifications.§ Review and revise stability specifications.§ Prepare accurate data graphs per FDA guidelines to estimate product shelf-life for annual product reviews.§ Conduct performance reviews of stability staff. Knowledge, Skills & Abilities: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.  Basic computer skills, including knowledge of ScienTek, WordPerfect, Excel, Turbochrom, E-Mail. Must be capable of using copy machine, fax machine, telephone, hardware and data systems, analytical chemistry instruments.  Must have a full range of motor skills.  Must be flexible and able to handle multiple tasks. Education:Bachelor of Science degree in chemistry or a closely related field or an equivalent combination of education and experience.  Three or more years experience in a quality control environment.  Three to five years of analytical chemistry experience.