Project Coordinator - Summit, United States - TSR Consulting Services, Inc.

TSR Consulting Services, Inc. Summit, United States

3 weeks ago

Pharmaceutical / Bio-tech

Description

Our client, an established pharmaceutical company is in search of a Project Coordinator to join their team on a W2 contract in Summit, NJ.

Job ID: 79359

The Project Specialist, provides project management support ensuring projects are executed within established quality metrics, budgets and timelines. This includes planning, developing, implementing and evaluating projects, coordinating project activities, collaborating with project team members, developing measurable project goals and objectives and monitoring progress toward achievement. This also includes supporting the development of project management and continuous improvement competencies. The Project Specialist participates in project development, disseminates project information and is an active participant in project execution.

Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, SBO (Strategic Business Operations) and the broader MSAT organization.

Execute project activities.

• Organize and conduct project team meetings and facilitate discussions.

• Participate in department and site project teams.

• Generate project documentation (e.g. schedules, status reports) and manage activities according to site objectives and timelines.

• Demonstrate basic understanding of site quality GxP systems supporting document management, change controls.

• Participate in planning project related implementation tasks.

• Interact and collaborate with internal departments, as well as external stakeholders as needed.

• Support development of project management and continuous improvement competencies, perform training.

• Support department staff by:

• Tracking performance against plan for project activities and deliverables.

• Compiling project related information, preparing budget proposals and reports in a timely manner.

• Documenting project risk identification and mitigation plans.

• Update project status weekly through the Tier board and iPLAN project dashboards.

Specific Knowledge, Skills, Abilities:

• Project management experience using proven methods/tools. Ability to utilize tools like MS project and Smartsheet is a must

• Excellent prioritization skills

• Able to partner with other groups and make meaningful connections. Being able to negotiate and proactively remediate and prioritize

• Basic knowledge of cGMPs and multi-national biopharmaceutical/cell therapy regulations

• Must be detail oriented and able to oversee/manage multiple projects, with a proven track record of impeccable time management, to meet timelines

• Possess strong verbal/written communication skills to enable working with internal/external parties and/or leading cross-functional teams

• Intermediate knowledge of evaluating data using statistics and statistical tools, to make data driven decisions

• Ability to think strategically and to translate strategy into actions

Education, Experience/Licenses/Certificates

• Bachelors degree required, preferably in Science or Engineering.

• 4 years relevant work experience required, preferably in a regulated pharmaceutical environment.

• Experience within a PMO (Project Management Organization) and/or PM (Project Management) preferred

• An equivalent combination of education, experience and training may substitute.

• Experience with Operational Excellence and Lean Manufacturing is a plus

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