What are the responsibilities and job description for the Technical Writer (Scientific) position at Zenith LifeScience?
Job Description
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 testing lab activities, on an as needed basis.
Job Qualifications
BS in Chemistry, Biology or a related scientific discipline.
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, TrackWise, 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.
Must be able to work onsite 3 days per week or may be more, as needed.
Scientific background, ideally pharma experience needed.
