POSITION SUMMARY

The Quality Assurance Engineer II supports quality systems, provides Quality oversight for manufacturing and Quality Control laboratories, and drives continuous improvement across GMP manufacturing operations. Partnering with MSAT, Manufacturing, and Validation to maintain the manufacturing facility, processes and procedures, enduring the safety, efficacy and compliance of cell therapy products.
The Quality Assurance Engineer II supports the qualification and validation activities for QC and manufacturing equipment and facility design. Additional responsibilities include oversight of site Change Controls, Investigations, and CAPAs as well as product release, batch record review, and participation in audits/inspections. The Quality Assurance Engineer II will support any new product transfers to the Raleigh site.

EDUCATION AND EXPERIENCE

• Bachelor’s degree or master’s degree, preferably in a Life Science, with 5+ years relevant experience in a bio-pharmaceutical company.
• Working knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity.
• Understanding of aseptic manufacturing.

TECHNICAL SKILLS REQUIREMENTS / CORE COMPETENCIES

• Ability to adapt Quality System elements for Pharma to cell/gene manufacturing.
• Normally receives little instruction on routine work; details instructions on new projects or assignments.
• Ability to set and manage priorities and schedule activities accordingly.
• Works on problems of moderate scope, requiring analysis of situations and data through the review of various factors.
• Exercises judgement within defined practice to determine appropriate action.
• Strong analytical and problem-solving skills.
• Accountable for making independent decisions with minimal supervision.
• Excellent organizational skills with attention to detail and deadlines.
• Strong written and verbal communication skills. Demonstrated interpersonal skills to work effectively with peers, managers, and cross-functional teams.
• Ability to work in a fast-paced team environment.

PHYSICAL POSITION REQUIREMENTS

This is an in-person, on-site, position, within our Raleigh site. Must be able, willing to work in a clean room, BL 1-2, or similar space within a GMP manufacturing environment. Must be able to work at a computer for multiple hours at a time. Must be able to review paperwork for multiple hours. Must be able to pass vision screening for product inspection

• Provide quality engineering input in the design, development, installation, validation, and qualification of equipment/processes/ systems
• Ensure that validation and qualification activities are consistent with company validation policies and procedures and site validation master plan
• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures
• Ensure method qualifications, method transfers, aseptic room qualification, environmental monitoring qualification and technical transfers meet company and regulatory requirements.
• Lead and participate in quality investigations, root cause identification and resolution (CAPA) for various types of quality or manufacturing related issues
• Review and approve investigation reports to ensure they contains the appropriate level of detail; and appropriate CAPA’s are identified
• Oversee and participate in the Change Control process including the authoring, review, and tracking of Change Controls
• Author and/or review SOPs for cGMP compliance and compliance to corporate policies and procedures
• Represent Quality Assurance on project teams to assure that quality objectives are met
• Issue and review Batch Production Records and QC Assay forms
• Participate in internal and external audits and inspections
• Review QC test data for completeness and accuracy
• Release incoming raw materials as well as finished goods
• Oversee manufacturing operations within production
• Inspect final product for defects
• Perform risk assessments and support FMEA activities for new and existing processes
• Monitor and analyze quality metrics to identify trends and drive improvements
• Collaborate cross-functionally with Manufacturing QC, Regulatory, and R&D teams