Summary: This position will be an integral part of the team that supports inspections through the preparation, performance and follow up of items requested by international regulators. It supports regulatory inspections and partner audits in the creation and management of inspection content ensuring it is organized, current and readily accessible during operations. This position will assist in inspection preparation and following up on identified items, which requires this individual to be quality minded, highly organized and to have the ability to work independently. This position will help coordinate the cross-functional team’s preparation for and follow up on inspection items as well as performing administrative duties in support of site inspection readiness. The role also requires an unwavering commitment to a culture of trust, teamwork and transparency.
Essential duties and responsibilities include but are not limited to the following:
- Assist with compiling information and requests in support of site registration requests, regulatory inspections and partner audit operations. To include determining the content required to fill those requests.
- Maintain action lists and follow up on the completion of actions in support of site inspection readiness. Including review of actions to determine if they are sufficient to close items.
- Prepare action reports for IMT and site personnel including but not limited to weekly status updates, metrics, operation reports.
- Develop good communication and working relationships with site functional areas to include department leaders and line managers.
- Maintain team documents and records ensuring content is accurate and up to date supporting inspection readiness. Manage documents both written and electronic and those stored on the IMT SharePoint.
- Support logistics during inspection operations in assigned inspection role.
- Support and coordinate internal meetings and or meetings with site departments
- Schedule and organize meetings
- Take meeting minutes
- Follow up on assigned actions with other groups
- Perform updates of inspection readiness documentation (i.e. opening presentation or inspection binders).
- Lead or support additional projects and activities as assigned by supervisor
- Seeks to continuously improve process and systems.
Knowledge and Skills:
- Must be quality minded, action oriented and highly organized
- Must display strong interpersonal communication skills and the ability to interact with team members with tact and diplomacy
- Must have the ability to handle multiple priorities and tasks with time management skills and prioritizing tasks for completion.
- Computer skills needed; proficiency in MS Office (Word, Excel, PowerPoint) and experience with SharePoint
- Must have the ability to successfully coordinate activities with site functional departments
- Promotes a GxP and Quality mindset at all levels
Education and Experience:
- Bachelor’s degree in a physical science 2 + years of GMP experience.
- Associates degree with 5+ years of equivalent/relevant experience may be substituted in lieu of advanced educational requirement. Required for candidate to have GMP experience.