Regulated Scientific Writer: GMP Reports & LIMS Data
SGS Consulting
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Job summary
SGS Consulting seeks a science-focused technical writer to author reports, SOPs, and regulatory documents for protein therapeutics. You will review protocols, participate in CMC submissions, and coordinate investigations and non-conformance records with cross-functional teams.
The role requires 2–3 years of lab experience, proficiency in scientific writing, and experience with Empower, LIMS, TrackWise, SAP/SRM, and Veeva in a regulated setting.
Qualifications
- Minimum 2–3 years scientific/analytical lab experience, preferably in protein therapeutics or monoclonal antibody therapies.
- Proficient in scientific/technical writing.
- Experience with Empower chromatographic data system and LIMS, SAP/SRM, TrackWise, and Veeva.
Responsibilities
- Author technical reports, policies, and Standard Operating Procedures.
- Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
- Author investigations, deviations, change controls, and other non-conformance records.
- Work with vendors to coordinate testing and arrange shipments as needed.
- Compile and review scientific data for completeness as needed.
- Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
- Use of LIMS database including protocol setup, data entry/approval, and data trending.
- Coordinate document review, approval, and archiving.
- Participate in analytical lab activities, on an as needed basis.
Skills
Education
Tools
Job description
SGS Consulting seeks a science-focused technical writer to author reports, SOPs, and regulatory documents for protein therapeutics. You will review protocols, participate in CMC submissions, and coordinate investigations and non-conformance records with cross-functional teams.
The role requires 2–3 years of lab experience, proficiency in scientific writing, and experience with Empower, LIMS, TrackWise, SAP/SRM, and Veeva in a regulated setting.
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