What are the responsibilities and job description for the Technical Writer position at Joulé?
Job Title: Technical Writer
Location: Exton, PA
Hours/Schedule: Mon- Fri 8-5
Type: Contract
Responsibilities
Location: Exton, PA
Hours/Schedule: Mon- Fri 8-5
Type: Contract
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
- Experience in Empower chromatographic data system
- BS in Chemistry, Biology or a related scientific discipline.