Stability Specialist

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The Stability Specialist is responsible for the planning, tracking and operation of all stability studies on site. This job requires the ability to demonstrate a high commitment to interpersonal relations. The Stability Specialist reports to Quality Assurance (QA) management and works closely with Quality Control and Microbiology Department Management.

This position presents the employee with an opportunity to play a key role in stability studies which includes study creation, study management, sample pulls, sample/study initiation, analytical testing, regulatory compliance and data management, while simultaneously learning the technical skills required to advance in the field of stability studies.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

At all times, comply with PDI Code of Integrity and Professional Conduct

• Performs a variety of activities to help administer the stability program at PDI
• Responds to customer requests for information concerning stability studies
• Collaborates with R&D, Planning and QA in the initial drafting and revision of stability protocols and final reports
• Prepares and reviews final stability data summary reports, as well as performs any needed stability trending as outlined in the stability protocol, for Annual Product Review (APR and those associated with specific product and process investigations.
• Assess current processes and provide solutions for increasing efficiency and regulatory compliance
• Performs investigations related to stability storage conditions being out of limits and assists in data evaluation associated with product/process investigations
• Writes deviations, OOS and NC/CAPA investigations/reports
• Prepares samples for inclusion in stability studies, including labeling and distribution to the appropriate stability chamber
• Removes samples from stability chambers according to protocol pull schedules and submits them to the appropriate testing group or outside customer
• Maintains stability chamber inventory and monitors chamber performance
• Utilizes a Laboratory Information Management Software (e.g. Labware LIMS) to manage and track studies to completion
• Perform quarterly inventory of stability samples, special attention to control samples. Maintains thorough knowledge and understanding of all Standard Operating procedures (SOPs) pertaining to testing, review, and equipment calibration and maintenance.
• Maintains thorough knowledge and understanding of general SOPs, GMP/GLP and ISO regulations as it pertains to work performed in the laboratory.
• Maintains knowledge of current compendia and testing methods as they apply to stability studies and knowledge of FDA guidelines regarding stability requirements.
• Able to work with minimal guidance to take a project from start to finish
• Adherence to relevant SOPs governing documentation.
• Adherence to applicable PDI personnel policies
• Participation in general staff meetings and training sessions as scheduled by QC Laboratory Management.
• Other duties as assigned

PERFORMANCE MEASUREMENTS

• Development and execution of stability related processes which enable rapid product development, product commercialization, product quality and operational excellence.
• Stability testing and reports are completed on time per procedure
• Internal and external customer requests for stability data / reports are provided in a timely manner