Business Unit: Point of Care
Requisition Number: 247830
Primary Location: United States-Indiana-Mishawaka
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: No
Are you the ready to work in a fast-paced manufacturing environment with cross-functional focus? You will be involved in supporting a newly established reagent manufacturing system as well as future integration projects within an Immunoassay product line.
· Site administration of document control system, employee training, and batch and/or batch releasing for immunoassay product line.
· Support design transfer of new production coming into the facility, including validations, process controls, procedures, process monitoring, and other commissioning activities.
· Perform procedural review and approvals.
· Troubleshoots and resolves problems associated with document control system tool.
· Completes a wide variety of complex administrative assignments.
· Obtains, correlates, and analyzes technical information needed to complete batch records.
· Meets with Quality Assurance personnel to establish production requirements for material
presented to customers and others.
· Completes the preparation of reports, charts, graphs, and other documents as necessary.
· Coordinates and facilitates the maintenance of the archive room for all controlled documents.
· Lead responsible for organizing and maintaining key technical manuals.
· Works collaboratively in a cross-functional team of Engineers, Manufacturing and Scientists from multiple groups.
· May lead meetings when assigned to continue projects either for scheduling, batching, document control or employee training.
· Maintains employee training database.
· Collaborates with regulatory affairs team to ensure all country specific requirements are maintained in SAP for batch release.
· Interact with multiple functions across sites including Engineering, Manufacturing, Technical Operations, and Regulatory Compliance.
Required Knowledge/Skills, Education, and Experience
· B.A. or B.S. Organizational Management or equivalent experience
· Thorough understanding of MDSAP country standard requirements for medical device or pharmaceutical operations.
· Experience working with Immunoassay based technology, specifically involving a troponin assay
· Experience performing data analysis as well as formal report writing.
· Experience creating and modifying testing protocols and supporting documents.
· Familiar with document control systems and their administration.
· Able to work independently and manage tasks assigned on schedule.
· Strong scientific, communication, and organizational skills are a must.
· Experience with Microsoft Office Suite for administrative document manipulation.
Other characteristics of the successful candidate:
· Very organized, detail-oriented
· Highly self-motivated
· Able to work independently
· Excellent analytical, communication, writing, and problem-solving skills
· Effective and influential in his/her interactions in team-based assignments
· Able to work well with personnel from different departments, and experience levels