Senior Documentation Area Specialist - FFEx
Novo Nordisk
- Clayton, NC
- Permanent
- Full-time
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Senior Documentation Area Specialist - FFExFacility: Reg Affairs & Safety PharmacovigilanceLocation:Clayton, NC, USAbout the DepartmentYou will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees.FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.What we offer you:
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance - effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
- Design & own process for implementation of new & revised documents, to include change control, document creation, assessment of training/documentation & routing/approval process
- Serve as editor in documentation control process with focus on compliance that guarantees ease of use for document owners, users & quality approvers
- Provide system administration leadership for SAP Plant Maintenance data processes
- Collaborate cross-functionally & maintain productive stakeholder relationships
- Support authors in the writing process with language usage, document control process & related software
- Serve as SOP Subject Matter Expert
- Provide specialist leadership on the writing process to ease understanding, choice of document type, structure & language usage of the operational documents
- Gain technical understanding of applicable plant operation processes and apply technical knowledge during the creation and revision of documentation
- Serves as Utilities organization lead deviation investigator as part of the site incident investigation process
- Serve as mentor for junior specialists, training them in the knowledge of incident investigations & standards in operational documents
- Lead documentation standardization projects as needed
- Process documents via applicable Novo Nordisk document management tools
- Develop documentation performance indicators and drive improvement through them
- Accountable for documentation related deliverables completed with metrics & timelines realized
- Follow all safety and environmental requirements in the performance of duties
- Other accountabilities, as assigned
- Bachelor's degree in business or a technical field of study from an accredited university required
- May consider an Associate's degree in business or a technical discipline from an accredited university with ten (10) years of experience in technical writing required, preferably in engineering, life sciences, or related industries
- May consider a High School Diploma or equivalent with twelve (12) years of experience in technical writing required, preferably in engineering, life sciences, or related industries
- Minimum of eight (8) years of experience in technical writing, preferably in engineering, life sciences, or related industries required
- Minimum of five (5) ears of experience with SAP PM and/or MM required
- Demonstrated strong skills in change management within a regulated environment required
- Proven expertise in GxP incident investigations and regulatory audit support preferred
- Ability to read, write & understand complicated product documentation, standard operating procedures, & P&IDs with attention to high-level technical process concepts preferred
- Expertise in GMP concepts & knowledge of process improvement methodologies such as LEAN and RCFA preferred
- Proven expertise in planning/organizing and executing resolutions for complex problems solved by cross functional teams preferred
- Strong communication and organizational skills preferred