Technical Writer
Job Responsibilities:
- Author technical reports, policies, and Standard Operating Procedures.
- Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
- Author investigations, deviations, change controls, and other non-conformance records.
- Work with vendors to coordinate testing and arrange shipments as needed.
- Compile and review scientific data for completeness as needed.
- Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
- Use of LIMS database including protocol setup, data entry/approval, and data trending.
- Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
- Coordinate document review, approval, and archiving.
- Participate in analytical lab activities, on an as needed basis.
Skills:
- Proficiency in Scientific Writing/Technical Writing,
- Experience in Empower chromatographic data system,
- Experience with LIMS, SAP/SRM, Track Wise, and Veeva,
- Experience in GMP/GLP and/or a regulated industry.
Education/Experience:
- At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies.
- Proficient in scientific/technical writing.
- Experience in Empower chromatographic data system
- Experience with LIMS, SAP/SRM, Track Wise, and Veeva.
- Excellent oral communication, interpersonal and technical writing skills.
- Excellent organizational skills, demonstrate attention to detail.
- Experience in GMP/GLP and/or a regulated industry.
- Strong background in Microsoft applications such as Word, Excel, SharePoint a must.
- Advanced Excel knowledge is a plus.
- BS in Chemistry, Biology or a related scientific discipline.
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