Katalyst Healthcares & Life Sciences
Location: Rensselaer,NY, USA
Date: 2024-11-24T11:26:43Z
Job Description:
Responsibilities:
- Include, but are not limited to, the following.
- Organize and schedule meetings with various departments and teams.
- Maintain distribution lists to ease communication.
- Produce and distribute meeting minutes, as required, obtain feedback.
- Prepare and maintain monthly metric based on quality system data.
- Create monthly PowerPoint presentations for review by Data Governance Program Management Team.
- Coordinate document workflows to support certain Quality Events.
- Coordinate and route incoming questions related to Data Integrity.
- Update and maintain SharePoint pages used by The Data Governance Program Management Team.
Requirements:
- 1-3 years of experience working in an FDA regulated environment.
- MUST DEMONSTRATE WILLINGNESS TO LEARN.
- Experience with quality management systems including change control, incident management, and deviation management.
- Project Coordinator experience leading efforts requiring coordination between cross-functional teams within at least one area of systems validation - (e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.)
- Continuously drive to improve processes for improved performance.
- Excellent Technical writing and communication skills.
- Excellent analytical and problem-solving skills.
- Basic knowledge of FDA CFRs, EudraLex, and other biotech pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing).
- Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Information Technology) preferred.