Project Coordinator

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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.

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