Job Description

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.

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