QA​/QC Documentation Specialist

George Higginson is currently supporting a rapidly growing biologics-focused CDMO in San Diego that is preparing for significant commercial growth and expansion.

As part of several ongoing quality and laboratory initiatives, the team is seeking an experienced QA/QC Documentation Specialist to support GMP laboratory documentation activities, quality systems, analytical method documentation, and QC operations
.

This position is ideally suited to someone who has worked within a GMP QC laboratory or laboratory-facing QA environment and has hands-on experience supporting SOPs, analytical methods, method transfers, testing protocols, and quality documentation used in regulated laboratory operations.

• Start Date:
  
  July 2026
• Approximately 20 hours per week
• Hourly Rate: $50-75/hour depending on experience
• Primarily onsite with some flexibility depending on project requirements

• Review, manage, and maintain GMP laboratory documentation within the Quality Management System (QMS)
• Support the authoring, revision, review, and approval of SOPs, work instructions, laboratory procedures, and controlled documents
• Review and support analytical methods, method transfer documentation, validation protocols, testing protocols, and associated QC records
• Support documentation activities associated with analytical method transfers from development into GMP QC environments
• Assist QC and QA teams with compliant documentation practices, data integrity requirements, and document lifecycle management
• Support stability program documentation, sample management records, laboratory logbooks, and related GMP documentation
• Manage controlled document workflows, training assignments, document revisions, and archival activities
• Ensure compliance with cGMP, GDP, ALCOA+, and data integrity requirements
• Support inspection readiness activities and internal quality initiatives
• Collaborate closely with Quality, QC, Analytical Development, Manufacturing, and Technical Operations teams

• Bachelor’s degree in Chemistry, Biology, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline
• 5+ years of experience within GMP-regulated QC, QA, Analytical Development, or laboratory operations environments
• Experience supporting SOP creation, SOP revisions, and controlled laboratory documentation
• Experience reviewing or supporting analytical methods, method transfer documentation, validation protocols, testing protocols, or stability documentation
• Strong understanding of GMP laboratory operations and documentation practices
• Experience working with electronic Quality Management Systems (eQMS), document control systems, or laboratory informatics platforms
• Knowledge of ALCOA+ and GMP data integrity principles
• Experience supporting LIMS, Empower, laboratory system implementations, or validation documentation is highly desirable.

This is an excellent opportunity to join a growing biologics organization and play a key role in supporting critical quality and laboratory documentation initiatives during a significant period of expansion.

For a confidential discussion, please apply directly or contact George Higginson at AL Solutions.