Technical Writer Job at Katalyst CRO in ExtonMediabistro • Exton, PA, United States
Technical Writer Job at Katalyst CRO in Exton
Mediabistro • Exton, PA, United States
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job_description.job_card.job_descriptionBS 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, 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.
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 testing lab activities, on an as needed basis.
Requirements
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Technical Writer • Exton, PA, United States
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