SUMMARY/OBJECTIVE:
Under the supervision of a technical project manager, provide support for the project management of R&D and CDMO customer projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide support to the project management team for the life cycle of customer projects
- Coordinate the receipt/release of incoming material by generating the required PO’s, material specifications and obtaining the necessary release documentation.
- Work with cross-functional team members and external suppliers/vendors to ensure project related tasks are understood and delivered on time.
- Working in support of the project management team, participate in client meetings, including development of agendas, capturing meeting minutes and assigning action items.
- Maintains effective communication and working relationships among the project team.
- Help in the facilitation of on-site client on-site visits and working sessions.
- Work with the technical project management team to identify, monitor, communicate and resolve issues, scope changes, or other project objectives that may arise during project execution.
- Prepare and present project progress reports and presentations as required.
- Use the enterprise resource planning (ERP) system for POs, part numbers, invoicing, shipments, inventory, work orders
- Activity and backlog tracking, budget tracking, and follow-up to assist the PM team.
- Use Microsoft Project and Excel to manage project timelines and deliverables.
- Organize and maintain project files for clients on file sharing platforms (such as SharePoint).
- Carries out duties in compliance with all federal and state regulations and guidelines.
- Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.
- Remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- making suggestions for improvement
- learning new skills, procedures, and processes.
- Is available for other duties or overtime as required.
QUALIFICATIONS AND EXPERIENCE:
- HSD/GED required; Associates degree or bachelor’s degree is preferred. Will accept a minimum of 2 years relevant work experience in lieu of degree.
COMPETENCIES/SKILLS:
- Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
- Legible Handwriting
- Communicate clearly in writing and orally.
- Demonstrate practical knowledge of 21 CFR 210, 21 CFR 211, 21 CFR Part 11, Eudralex Volume 4, and Annex 13.
- Demonstrate effective collaboration and teamwork.
- Demonstrate experience working in a cGxP environment.
- Familiar with project management tools and technologies such as Microsoft Project.
- Successfully completes regulatory and job training requirements.
- Computer skills:
- Microsoft Word, Project, Excel, and SharePoint
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems.
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to work with others in a team environment.
SUPERVISORY RESPONSIBILITIES:
None
SCHEDULE:
Hybrid Role: 4 days in office in Cranbury, NJ office, 1-day WFH.
SALARY:
$60,000 - $75,000
WORK ENVIRONMENT:
Standard office environment with some operation in packaging/warehouse setting.
PHYSICAL DEMANDS:
Office Environment (standing and sitting) requiring minimal physical exertion.
TRAVEL:
Travel will be required less than 10% of the time.
