CMC/GMP Documentation & QC Senior Consultant (Remote)

Rang Technologies Inc; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Rang Technologies Inc. in Sunnyvale, CA, is seeking a Senior Consultant to provide long-term, hands-on support focused on CMC and GMP documentation review, with additional QC support related to technology transfer.

The role is embedded within CMC and Quality teams to help maintain regulatory readiness and inspection preparedness. This consulting position has no people-management responsibilities and offers remote work options.

Qualifications

• 10+ years of pharmaceutical or biotechnology CMC/GMP or Quality roles.
• Strong hands-on experience reviewing CMC and GMP documentation.
• Working knowledge of GMP requirements applicable to drug substance and product development.
• Experience supporting QC documentation, investigations, and data integrity requirements.

Responsibilities

• 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.

Job description

Rang Technologies Inc. in Sunnyvale, CA, is seeking a Senior Consultant to provide long-term, hands-on support focused on CMC and GMP documentation review, with additional QC support related to technology transfer.

The role is embedded within CMC and Quality teams to help maintain regulatory readiness and inspection preparedness. This consulting position has no people-management responsibilities and offers remote work options.