Job Description
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.
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