Job Description

Our Client, a Pharmaceutical company, is looking for an Associate Stability Research Scientist II for their Clayton, NC location.

• Daily, maintain product inventory for active stability studies in accordance with all compliance requirements by assuring the accountability and delivery of all stability samples and associated documentation as well as the issuance of required documentation for testing.
• Coordinate with Packaging to acquire samples for batches to be placed into the stability program for evaluation.
• Maintain label printers in good working order to ensure ability to fulfill printing of labels for stability requests.
• Maintain and audit all sample labeling and documentation for accuracy and compliance with GMP.
• Facilitate delivery of stability samples for laboratory testing and coordinate with QC Sample Specialists and stability supervisors to correct any discrepancies associated with stability samples for testing.
• Possess experience necessary to note any uncharacteristic property of the stability samples, as the last viewer of samples before they are sent to the laboratory for testing.
• Track requests for additional samples.
• Generate and review monthly pull schedules for all stability testing for all active studies.
• Generate work orders for preventative maintenance and repairs for all equipment associated with stability incubators to prevent product loss due to equipment failure. Ensure that the Preventative Maintenance program is executed in a timely manner.
• Assure compliance of all completed test request sheets for stability, as applicable.
• Experience in conducting a check-in process for receipt of data, when applicable, for data returned from the testing laboratories.
• Experience with entering test data into the stability databases, Stability System and/or SAP.
• Assist with filing of all stability records.
• Conduct investigations to document and resolve GMP discrepancies associated with sampling, labeling, and/or sample inventory.
• Remove samples from inventory and perform required documentation for completed stability studies.
• Initiate purchase orders and work orders for the Stability Group.
• Performs shipment of samples between sites.
• Trains Stability staff on sample handling and inventory procedures.
• Perform daily assessments of operation of the stability incubator and freezers.
• Conduct investigations for any excursions outside validated ranges (temperature for the stability incubators.
• Analyzes chamber temperature and humidity trends daily to evaluate for any issues. Performs weekly, monthly, and annual reviews to ensure all equipment remaining compliant, and as a preventative measure to address chamber concerns prior to any impact on studies.
• An understanding of ICH guidelines and GMP requirements set forth by regulatory agencies associated with the storage of Stability product is required. Good communication skills are needed to generate effective written and oral reports that are clear, accurate, and logical.
• The incumbent must possess excellent interpersonal and communication skills to interact effectively and promptly with all levels of the organization, supporting departmental objectives and management decisions, and maintaining good working relations with multiple cross-functional teams.
• The incumbent must possess a working knowledge of equipment and storage facility operations and be able to quickly resolve problems associated with chamber related issues. The incumbent must possess excellent skills regarding determination of the impact of a deviation upon the stability program and be able to ensure corrective actions for each discrepancy have been implemented and are effective to prevent reoccurrence. The incumbent must possess computer skills regarding working use of word-processing, spreadsheet, and e-mail programs. Training and working knowledge on the following are required for consideration for this position: ScienTek Stability System program, Loftware labeling solutions software and Intermec printers, SAP, DeltaV Monitoring System, LabWatch, Maximo Management System and TempTale Monitoring Devices. Prior experience with visual inspection and vial integrity testing is necessary, as is experience with shipment of biological samples. This position requires the ability to perform basic calculations in addition to the need for keen assessment skills and extreme attention to detail. The incumbent must possess effective verbal and written communication skills. The incumbent must keep neat, accurate, complete, and timely records. They must demonstrate initiative and willingness to learn.
• The incumbent must be able to carry out tasks independently or with minimal supervision and be able to function in a team environment. The responsibilities of this position directly affect the quality of marketed and developmental products stored in the Stability program, which are valued in the millions of dollars.

Job Tags

Similar Jobs