Technical Writer

Company: Joul--
Location: Exton
Posted on: April 6, 2025

Job Description:

Job Title: Technical Writer

A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible.
Location: Exton, PA
Hours/Schedule: M-F 8-5
Type: Contract, Potential for extension or conversion to permanent

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 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.



Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.


Ref: #558-Scientific

Keywords: Joul--, Lower Merion , Technical Writer, Advertising , Exton, Pennsylvania