What are the responsibilities and job description for the Project Manager - R&D position at SPECTRUM INTERMEDIATE LLC?
Description
Introduction
For over 14 years, Spectrum Solutions has been a single-source provider of high-quality consumer product innovation providing customers measurable process optimization, unmatched scalability, and overall cost savings. With full-service on-site manufacturing, custom packaging, kitting, fulfillment, and global logistics, our technology, products, and services provide the industry with full product development-to-delivery solutions.
Our commitment and mission are to: "Build the best products. Champion the simplest solutions. Deliver as promised". At Spectrum we believe that opportunities and creativity pave the way to innovation. Here your passion, resourcefulness, and perseverance will do more than just join something, they will add something.
We are looking for a Project Manager to work in our Draper, UT location. The Project Manager will Fulfill responsibilities by planning, directing, and coordinating activities of each designated project to ensure that goals and objectives are met and accomplished within designated time frame and funding parameters by performing the following duties.
Job Duties and Responsibilities:
- Interface with management and department heads to review project proposals/ plans to determine time frame, funding limitations, procedures for accomplishing project, staffing requirements, and allotment of available resources to various phases of project.
- Confers with project staff to outline work-plan and to assign duties, responsibilities, and scope of authority.
- Manage and deliver a DHF compliant with BIT, R&D Process and 21 CFR Part 820
- Ensure Development Process Follows Internal Quality, ISO, and FDA Requirements
- Maintain contact with client during all of the development phase
- Define project tasks and resource requirements
- Develop full scale project plans and project budget
- Plan schedule and manage project timelines
- Track project deliverables using appropriate tools and metrics
- Provide direction and support to project team
- Ensure and maintain development process according to ISO and FDA 21 CFR 820 requirements
- Maintain Change Control/Change Management
- Worked with R&D and concept with commercialization
- Other duties, as assigned
Requirements and Qualifications
- Proven experience in project management
- Proven experience in risk management
- Goal oriented –able to set, reach and exceed goals
- Project Management certifications
- FDA/ISO environment 210, 211, 820 GMP or drug device companies
- Understanding of ISO, Quality Systems, inner workings of Q.A. system
Education/Experience:
- High School Diploma Required
- Bachelor’s Degree from four-year-college or university preferred
- Two years related experience and/or training; or equivalent combination of education and experience.
Computer Skills:
- Strong Microsoft Office skills (Excel, Word, etc.)
- To perform this job successfully, an individual should have knowledge of Spreadsheet Software; Inventory software; Project Management software and Contact Management systems.