The primary focus of the Quality Specialist I will be to coordinate stability studies for our Large Volume Liquid Manufacturing area and support all stages of the studies. In this role, the Specialist will be required to implement, manage, and ensure regulatory compliance of stability programs for customer requests. He or she will write the stability protocols, perform data analysis and trend data over the lifecycle of the study. He or she will interact with all Quality Control laboratories, Regulatory, Program Management and Research and Development.
- Design & write test protocols to meet requirements as defined in project scope
- Stores test samples and distributes to the proper labs at specified time points
- Occasionally completes tests per protocols as dictated by department workload needs
- Provides reports and monitors test progress throughout the study to ensure adherence to project timelines
- Trends and assesses data to track program effectiveness and proactively identify areas of risk
- Participates in root cause analysis as applicable to stability program failures
- Updates test protocols as needed to maintain regulatory requirements
- Contributes ideas and suggestions to improve cell culture media manufacturing environment to enhance protocols, processes and equipment.
- Reports all non-compliance and support, engage in, and potentially lead teams assigned to making improvements.
- Demonstrated experience in the analysis and assessment of technical and/or stability data
- Familiar in Laboratory testing and methods.
- Strong written, verbal, and organizational skills, and the ability to work independently with cross-functional teams.
- High degree of proficiency in writing protocols and reports.
- Ability to work in a high paced team environment, prioritize multiple stability workflows and projects.
- BS/MS in relevant scientific discipline