at VIVA USA Inc. in Newark, Delaware, United States
The Manufacturing Documentation Specialist will serve to construct the documentation to allow Manufacturing systems/specifications, work instructions, the sourcing of raw materials, the production scheduling and instructions for assembly of medical devices to be established. These activities will occur primarily in the phase of new product development where new product designs are transferred from R&D into manufacturing. As such an individual in this role will be required to complete such tasks as:
(a) apply an understanding of the product and collaborate with the manufacturing areas to generate written work instructions for specific manufacturing areas related to that product,
(b) complete the documentation to establish or alter bills of materials for newly introduced products within a SAP-based MRP system,
(c) construct procurement documentation including specifications that are provided to vendors and receiving work instructions used to disposition the raw materials upon arrival at the manufacturing plant,
(d) manage the approval of quality related manufacturing documents within the Healthiness document management system,
(e) prepare manufacturing quality deviations whenever a variance from an established quality procedure is required,
(f) manage the documentation and process, including working with our global logistics organization, to facilitate movement of materials into and out of inventory as necessary. In executing these are other similar tasks, the Manufacturing Documentation Specialist will be required to work in a highly collaborative manner with a number of cross functional teams and as such must possess excellent oral and written communication skills, be an excellent “team-player” and have an excellent understanding of the suite of Microsoft Office applications. Experience in operating in a FDA-regulated manufacturing environment is highly desired as is experience in technical writing, SAP or other MRP systems and in utilizing Microsoft Office.
8:00 AM 4:30 PM
The position can be executed primarily remotely. A local candidate is preferred in the event that a need arises for the candidate to appear on-site.
However, for experienced, well-qualified candidates the position can be done completely remotely from a distance with no requirement to be on-site.
Looking for someone with a Biological/Chemical Scientist/Engineer background.