Job Description

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

Job Tags

Similar Jobs