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
Job ID: 189300
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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