USA-Technical Writer II (IT)
The Fountain Group · Swiftwater, PA · 1 wk ago
On-siteInformation Technology$54/hrContract
Key Responsibilities
- Configure and maintain OneLIMS master data to support Environmental Monitoring implementation.
- Align Continuous Process Verification (CPV) program data with global standards.
- Transfer process monitoring trend limits into OneLIMS.
- Develop and maintain technical and quality documentation, including SOPs, validation documents, and related records.
- Create training materials and documentation for system implementation.
- Support future-state process mapping and quality system workflows.
- Track master data reviews and project deliverables.
- Ensure compliance with cGMP and quality system requirements throughout implementation.
Requirements
- Bachelor's degree in Science, Engineering, or a related discipline required.
- Minimum 2+ years of relevant industry experience.
- Hands-on experience with OneLIMS/LIMS or similar Laboratory Information Management Systems required.
- Experience with quality applications such as Veeva and LIMS platforms required.
- Experience Working In Biotechnology Or Pharmaceutical Manufacturing Environments Required.
- Knowledge of cGMP/GMP regulations and quality documentation required.
- Technical documentation including SOPs, validation documentation, and training materials required.
- Master data management and process monitoring support required.
- Experience Supporting Laboratory Or Quality System Implementations Required.
- Ability to work independently in a fast-paced regulated environment required.
Skills
- Experience with OneLIMS Environmental Monitoring (EM) implementations.
- SQL (Sequel) experience for data analysis and reporting.
- Experience with process mapping and project deliverable tracking.
- Experience with Qualipso.
- Knowledge of Continuous Process Verification (CPV) methodologies.