The PositionDesigns, improves & maintains the document creation & revision process for QC documents at site Clayton in order to support Process Responsible personnel on-site. Serves as English language technical writing expert for QC documents. Leads, trains, coaches & mentors other QC technical writers & SME's working to establish documents.
RelationshipsReports to Manager, QC Support.
Essential Functions- Design & own process for implementation of new API, IFP, & OFP (Local & Framework) QC documents, to include change control, document creation, assessment of training/documentation & routing/approval process
- Improve local change process for revision of QC documents, with focus on compliance with existing procedures in a way that guarantees ease of use for document owners, users & quality approvers
- Collaborates cross-functionally with other departments & maintains stakeholder relationships
- Supports authors in the writing process with language usage, document control process & related tools
- Reviews local QC documents to ensure clear & reader friendly language
- Participates in SOP Expert Network, Process Workshops, & other document governance groups
- Provides specialist knowledge on the writing process to ease understanding, choice of document type, structure & language usage of the operational documents
- Coaches' others in the knowledge of good communication & standards in operational documents
- Supports &/or leads QC standardization projects as needed
- Supports the document processing of revisions to API, IFP, & OFP Framework level documents in collaboration with QC process work packages
- Ensure projects are completed with metrics & timelines realized
- Other accountabilities, as assigned.
Physical RequirementsAbility to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).
Qualifications- Bachelor's Degree or equivalent combination of education & experience required
- Minimum five (5) years of experience in technical writing, preferably in engineering, life sciences, software, or related fields required
- Ability to read, write & understand complicated product documentation & standard operating procedures with attention to high-level concepts required
- Knowledgeable in core work processes & GMP concepts; knowledge of process improvement methodologies such as LEAN preferred
- Proven expertise in planning/organizing, managing, executing preferred
- Revising the work plan preferred
- Schedules for complex problems solved by cross functional teams preferred
- Demonstrated strong skills in change management within NN preferred
- Communication Skills: Must be ability to communicate effectively with various stakeholders in Novo Nordisk preferred
