Quality Assurance Manager

1 Year Contract

Cambridge, MA

PR: $55-62/hour

Job 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.

Education & Qualifications

Required

• Bachelor’s Degree in Biology, Microbiology, Chemistry or related field
• 4 years of experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy product manufacturing

Preferred

• Master’s Degree in Microbiology, Biology, Chemistry or a related field
• Working knowledge of cell or gene therapy product testing, manufacturing, or development
• 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 required.