Responsibilities

Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids, etc.) needed for internal manufacturing operations.

Review logbooks and reconcile documentation.

Assist with walkthroughs with senior Quality staff members.

Review labeling and packaging batch records and prepare documentation for release.

Review work orders, equipment qualification, and validation documentation for adequacy and compliance.

Review batch record documentation, ensure compliance and accuracy, and prepare for drug substance/product and/or critical material release.

Engage in daily onsite quality oversight and guidance and collaborate across functions, leveraging quality and manufacturing expertise to provide guidance on non-conformance/deviations, troubleshoot/problem solve, interpret data, and apply a risk-based approach for ongoing manufacturing operations and related quality events.

Represent QA in onsite operations from the thaw of starting material to drug substance/product filling and labeling.

Additional duties as assigned.

Requirements

Master's Degree in Microbiology, Biology, Chemistry or a related field.

Working knowledge of cell or gene therapy product testing, manufacturing, or development.

5+ years of experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy product manufacturing.

Demonstrated knowledge of current GMP regulations associated with pharmaceuticals, cell therapies, gene therapies, etc. in the field of responsibility.

Understanding and working knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions, and respond rapidly to emerging quality situations. in the field of responsibility.

Local travel between manufacturing sites is required.