Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 1 Month(s)
Skills
Documentation
Change Control
Collaboration
Computerized System Validation
Document Management
GAMP
Job Details
We are looking for Technical Writer/Validation Specialist (Life Sciences) for our client in West Point, PA
Job Title: Technical Writer/Validation Specialist (Life Sciences)
Job Type: Contract
Job Description:
Pay Range: $35hr - $40hr
- Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents.
- Translate complex scientific and technical concepts into clear, concise documentation.
- Collaborate with SMEs to gather and verify technical information.
- Ensure documentation complies with industry standards (GxP, ISO, ICH).
- Manage document lifecycle using electronic document management systems (EDMS).
- Author and execute validation protocols (IQ/OQ/PQ) for equipment, software, and processes.
- Perform Computer System Validation (CSV) in accordance with 21 CFR Part 11 and GAMP 5.
- Conduct risk assessments and support change control processes.
- Review and approve validation documentation and reports.
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