Day to day management of a production process, management of a process flow that occurs across several departments.
Schedule, coordinate and may perform execution of the stability testing with the QC Operations.
Review, approve and organize product stability data and study report.
Participate in the planning and review of real-time stability design and/or protocol.
Review data, evaluate trend, address specifications or compliance challenges related to stability.
Escalate out of specification results encountered during the stability testing.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Ability to understand and follow work instructions with little guidance.
Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
Self-starter, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, a are essential.
GMP and GLP experience a plus
Knowledge of molecular assays, sequencing technology or related lab assays are a plus