Senior GMP Documentation & QC Consultant

eTeam; Sunnyvale (CA); Hybrid; USD 150,000 - 230,000; Full time

Job summary

eTeam is seeking a Senior Consultant, CClient / GMP Documentation & Quality Control in Sunnyvale, CA, for a 12-month engagement. The role focuses on expert review of CClient and GMP documentation with support for QC activities related to technology transfer.

The candidate will operate as a senior SME embedded within CClient and Quality teams, aiding regulatory readiness, inspection preparedness, and remediation of documentation gaps.

Qualifications

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree preferred).
• 10+ years of experience in pharmaceutical or biotechnology CClient, GMP, or Quality roles.
• Strong hands-on experience reviewing CClient and GMP documentation.
• Working knowledge of GMP requirements applicable to drug substance and drug product development.
• Experience supporting QC documentation, investigations, and data integrity requirements.
• Demonstrated ability to identify documentation gaps and drive corrective actions.

Responsibilities

• Perform detailed quality review of CClient 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 CClient and GMP documentation is inspection-ready, accurate, and complete.
• Assist with responses to regulatory questions, inspection observations, and information requests related to CClient and QC topics.
• Review CClient 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 CClient, QA, Regulatory Affairs, and external partners.

Skills

10+ years experience

GMP documentation review

Quality Control

Regulatory readiness

Data integrity

Education

Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline

Tools

QMS platforms

Electronic document management systems

Job description

eTeam is seeking a Senior Consultant, CClient / GMP Documentation & Quality Control in Sunnyvale, CA, for a 12-month engagement. The role focuses on expert review of CClient and GMP documentation with support for QC activities related to technology transfer.

The candidate will operate as a senior SME embedded within CClient and Quality teams, aiding regulatory readiness, inspection preparedness, and remediation of documentation gaps.