Lab Support is currently working with a Biotechnology company located in Doral. They are growing at a rate of 20-30% year over year and are looking some great talent. This is an mid-level role with GREAT growth opportunities.
Working under general direction of the Senior Director , the Project Administrator plans multiple meetings to review supply chain, systems applications development and or business process projects and solutions. Responsible for partnering with the business in order to provide administrative support updating meeting minutes, plans, procedures and develop solutions that meet their needs. Provides communication support to the project team within content / documentation management system or business updates in order to ensure alignment with business and project objectives. The Project Administrator may be assigned to components or a project in the areas of supply chain, facilities, in support of remaining compliant with regulatory agencies.
Knowledge, Skills and Abilities:
1. Assist the Supply Chain Operations Division with processes to be compliant with GMP, FDA, GTPs, ISO and all other company Regulatory bodies
- Solid Technical Writing Skills writing procedures
- Biomedical / Engineering / Microbiology / Business/ Law / Finance B.A./B.S. Preferred
- Business Enterprise / Accounting / Quality Knowledge in regulated industry
- IT skills MS Projects / VISIO / Business Process Design / Exception Management and documentation control systems / methods
- Ability to understand engineering /ERP integration planning
- Regulatory / Paralegel Experience
- Ability to record User Requirements, System Requirements, Specifications
- Software Validation Experience, not essential
2. Assigns resources to meet project objectives for the multiple concurrent projects or one project with multiple deliverables or components being managed
3. Estimates material and other resource needs to meet project objectives
4. Provides input to the Supply Chain Management and Facilities Senior Director for project budgets and manages expenditures to project plan budget
5. Prepares or reviews project documentation and deliverables and assures it is completely acceptable and in accordance with standards
6. Facilitates project status meetings with the project team on a regular basis and provides consistent status to leadership
7. Provides updates and feedback to clients on progress
8. Directly and indirectly supports action plan development
9. Perform technical review of procedures, scope documents, planning work breakdown structures, facility and equipment projects
10. Coordinate planning meetings for product supply, business systems i.e. ERP, and support procedural development and project / documentation control
11. Coordinate follow-up on project deliverables action item status, action plans, scheduling meetings, establishing meeting minutes, contract management planning and technical writing of scope documents
12. Develop and perform internal control procedures of the supply chain division in order to ensure requirements are met from outside regulatory bodies as well as from the Bio-Tissue Quality department before they happen.
13. Work with other department managers/supervisors to resolve issues and problems concerning Supply Chain & Facility matters.
14. Track and Trend assigned metrics from each department and provide feedback regarding process improvements or issues as assigned
15. Ensure that all project administration activities are current for respective work streams / processes, processing equipment and systems within the Supply Chain & Facility department.
16. Verify and assist with supplier development and vendor implementation SOPs for the supply Chain & Facility division.
17. Verify and assist with the development and implementation of SOPs for the Supply chain & Facility Division.
18. Utilize all Computer Data Software systems as related to the Supply Chain & Facility Division
19. Assist in item master development for ERP system and establishing Part lists and BOM’s
20. Responsible for other duties and projects as assigned