Quality Assurance Operations Specialist

The Specialist, QA Operations will be responsible for supporting Quality's oversight of laboratory and manufacturing operations at Beam's manufacturing facility in RTP, North Carolina. The role will involve ensuring compliance to Good Manufacturing Practices and Good Distribution Practices, as well as supporting plant start-up and routine operations. The Specialist will provide quality oversight on the manufacturing shop floor, review batch records and manufacturing discrepancies, and assist with product disposition activities. They will also contribute to the development and improvement of quality systems, support resolution of manufacturing issues, and participate in regulatory inspections.

• Support Quality's oversight of laboratory and manufacturing operations at Beam's manufacturing facility in RTP, North Carolina
• Ensure compliance to Good Manufacturing Practices and Good Distribution Practices
• Provide Manufacturing Shop Floor Quality presence
• Conduct batch record review, logbook review, asset inductions, and work order approvals
• Release incoming raw materials and consumables
• Approve deviations/CAPAs
• Support product disposition activities
• Partner with other functional areas for site start-up activities, quality risk management, continuous improvement, and future scale-up
• Provide quality oversight of on the floor activities during manufacturing operations
• Ensure GMP compliance in QC, manufacturing, and facilities operations
• Assist with product disposition activities, including real-time review of batch records and labels, approval of manufacturing discrepancies, and communicating lot disposition pending issues to management
• Aid in the development and improvement of quality systems for the site, including identifying gaps or improvements, authoring and approving procedures, and providing training
• Review and approve calibration and maintenance work orders and asset inductions
• Support approval of validation protocols
• Provide Quality support for resolution of manufacturing issues related to material, product, environment, facility, and equipment
• Support functional and facility goals and objectives
• Contribute to quality metrics for the facility
• Support and participate in regulatory inspections

• Experience in quality oversight of laboratory and manufacturing operations
• Knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
• Familiarity with advanced therapeutic manufacturing technologies, specifically cell and gene therapy modalities
• Ability to review and approve batch records, logbooks, and work orders
• Experience in release of incoming raw materials and consumables
• Proficiency in handling deviations and CAPAs
• Understanding of product disposition activities
• Knowledge of quality systems development and improvement
• Familiarity with calibration and maintenance work orders
• Ability to support validation protocols
• Strong problem-solving skills
• Ability to contribute to quality metrics for the facility
• Experience in supporting and participating in regulatory inspections

• Competitive salary and compensation package
• Opportunity to work in a greenfield build manufacturing facility
• Exposure to advanced therapeutic manufacturing technologies (cell and gene therapy modalities)
• Chance to be involved in the start-up and routine operations of the facility
• Compliance with Good Manufacturing Practices and Good Distribution Practices
• On-site resource with alternate shift schedule
• Partnership with other functional areas for site start-up activities and ongoing continuous improvement
• Quality oversight of on the floor activities
• Development and improvement of quality systems for the site
• Support in resolving material, product, environmental, facility, and equipment manufacturing issues
• Contribution to quality metrics for the facility
• Opportunity to support and participate in regulatory inspections
• Alignment with company culture and values