Technical Writer Job at Kellton Tech, Exton, PA

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  • Kellton Tech
  • Exton, PA

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

Work at office, 2 days per week, 3 days per week,

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