Main Responsibilities & Tasks:

•Draft and review Standard Operating Procedures (SOPs)

•Support ongoing process improvement endeavors

•Maintain and ensure applicable regulatory and internal QMS compliance for staff training/personnel files, master schedule, deviation trending/tracking, etc.

•Provide support for internal and sponsored projects including reviewing protocols and reports

•Work collaboratively with staff responding to and resolving deviations and incidents

•Follow through on corrective and preventative actions from deviations and audit observations

•Maintain databases for investigations, audit observations and CAPA

Qualifications & Skills:

•Bachelor degree in Science, Engineering or related field

•Minimum 5 years related experience required

•Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems

•Knowledge of quality systems and product/process lifecycle management within a manufacturing environment

•Proficient computer skills required

•Excellent communications skills both written and oral, including ability to navigate potentially challenging situations both internal and external to the business during the coordination of QMS programs

•Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively in order to expedite the successful execution of assigned work

•Efficient organizational skills, including the ability to manage multiple processes and priorities effectively

•Good command of spoken, written English