What are the responsibilities and job description for the Coordinator, Project - Change Controls position at Exela Pharma Sciences?
Position Summary:
The Project Coordinator I – Change Controls is responsible for drafting and coordinating change controls associated with pharmaceutical projects while ensuring the change controls are executed in compliance with all applicable procedures by the designated milestones.
Job Responsibilities:
- Coordinate change controls varying in scope (R&D, construction, equipment, software, etc.) from inception phase to completion through the generation and tracking of change control/change action timelines
- As applicable, initiate change proposals and impact assessments with SMEs, track action items, and monitor change controls within the electronic quality management system (EQMS).
- Open change control records in the EQMS.
- Provide routine change control status updates
- Prepare minutes for internal and external meetings/teleconferences
- Communicate and escalate change control/project issues on a timely basis
- Perform tracking of materials and componentry required for projects
- Perform tracking of documentation required for change controls/projects
- Maintain change control status dashboard
- Perform other duties as assigned
Required Skills:
- Detail-oriented with exceptional planning and organizational skills
- Must be comfortable communicating at multiple levels within the business, to include verbal and electronic communication
- Ability to meet varying deadlines
- Ability to coordinate change controls involving input from multiple participants
- Ability to establish a good working relationship with both technical and non-technical personnel
- Ability to self-initiate and exercise independent judgment and analysis
- Excellent verbal and written communication skills
- Proficiency in Microsoft Office applications
Education and Experience Requirements:
- Bachelor’s degree in a scientific field preferred
- 3-5 years or more of pharmaceutical industry experience
- Must understand the pharmaceutical development cycle and the nomenclature associated with pharmaceutical development, including cGMP procedures and practices
- CAPM (or PMP) certification is a plus
