Technical Writer
Job Title: Technical Writer
Location : Exton, PA (Hybrid 2-3 days onsite per week, M F, 8 AM 5 PM)
Pay Rate : $38.00/hr on W2
Empower Experience Required
Candidate must have direct, hands-on proficiency in:
Empower Chromatographic Data System :
Configuration
- Creating methods
- Reports
- Custom calculations
Bonus : Experience in validation of custom fields in Empower.
Required Qualifications:
Education : BS in Chemistry, Biology, or a related scientific discipline
Experience :
- 2 3+ years in a scientific or analytical lab environment (preferably with protein therapeutics or monoclonal antibodies )
- Technical/scientific writing proficiency
- Empower system hands-on experience (not review-only or basic use)
- Familiarity with GMP/GLP and regulatory environments
Technical Skills :
- LIMS
- SAP/SRM
- TrackWise
- Veeva
- Microsoft Office (Advanced Excel a plus)
- SharePoint
Job Responsibilities:
- Author technical reports, policies, SOPs , protocols, validation reports, and CMC sections for regulatory submissions
- Create/review investigations, deviations, and change controls
- Coordinate with vendors for testing, shipping, and invoicing
- Compile, trend, and evaluate scientific/stability data
- Work within LIMS: protocol setup, data entry/approval, data trending
- Manage document lifecycle review, approval, archiving
- Support analytical testing lab activities as needed
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