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Quality Consultant - CMC and GMP Documentation - Remote/Telecommute
Remote / Online - Candidates ideally in
Sunnyvale, Santa Clara County, California, 94087, USA
Listed on 2026-03-08
Sunnyvale, Santa Clara County, California, 94087, USA
Listing for:
CYNET SYSTEMS
Remote/Work from Home
position Listed on 2026-03-08
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
Job Description :
Pay Range: $175hr - $180hr
- Perform detailed quality review of CMC documentation including specifications, batch records, validation documentation, stability protocols and reports, and technical reports
- Review GMP documentation for compliance with FDA, EMA, ICH, and other applicable global regulatory requirements
- Identify documentation gaps, inconsistencies, and compliance risks and recommend corrective actions
- Support QC documentation review activities related to analytical methods, test records, and data packages
- Provide QC documentation and quality review support for technology transfer activities, as needed
- Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies - Support inspection readiness by ensuring CMC and GMP documentation is inspection-ready, accurate, and complete
- Assist with responses to regulatory questions, inspection observations, and information requests related to CMC and QC topics
- Review CMC and GMP documentation generated by CDMOs, testing laboratories, and other external partners
- Provide clear, practical documentation feedback to vendors to drive compliance and quality improvements
- Collaborate closely with CMC, QA, Regulatory Affairs, and external partners.
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