General Responsibilities: The Quality Control Engineer will support the Quality Control department in technical projects, equipment qualification, statistical analysis of test results, data trending and reporting, and supplier qualification. They will apply good engineering practices to meet regulations to support clinical and commercial requirements. Responsibilities: Track, trend, and report on key quality performance indicators (KPIs), including out of specification results, analytical test results, and environmental monitoring results for the QC department Lead and execute risk assessments, gap assessments, FMEA, and continuous improvement plans to ensure product quality and regulatory compliance Design and execute corrective and preventive actions Provide technical input for control and validation strategies and effectively communicate strategies to internal and external stakeholders, including: Development of project design documentation Generating validation plans for equipment and test methods Compilation and review of validation protocols, executed data, and reports Execution of certain validation activities Testing data and documentation review

Utilize proven statistical methods and tools to evaluate product data Schedule and manage the qualification of new equipment and periodic re- evaluation/requalification of existing equipment and systems Collaborate with Maintenance regarding maintenance routines, including calibration and preventative maintenance to ensure timely execution and proper documentation Act as a quality control SME during change control planning and execution for projects which require input of a technical nature Participate in analytical test procedure process mapping Perform project management and scheduling functions as it relates to execution of quality control activities and ensures clinical material testing schedules are adhered Provide software quality and validation leadership and be the SME for GXP computerized systems. Apply risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 Interpret regulatory requirements for electronic and data integrity systems to identify, support and/or manage process improvement initiatives to ensure compliance with GxP regulatory requirements and Electronic Records/Electronic Signatures regulations Participate in inspection readiness for regulatory inspections

Oversee and execute software quality and validation strategy in support of custom software systems to improve the overall accuracy, efficiency, and effectiveness of electronic computerized systems Evaluate and recommend assay compliance changes by keeping abreast of the requirements for compliance. Participate and support the external audit program for vendors related to GXP computerized systems, equipment, and processes as it relates to Quality Control Effectively identify and resolve complex system issues and appropriately communicate gating items to senior management and stakeholders Computer Skills: Proficiency in use of Visio, PowerPoint, Microsoft Word, Excel, database management and statistical analysis software (JMP, Minitab, etc.). Experience with SolidWorks a plus Proficient in 21 CFR Part 11 and GAMP5 compliance requirements Education: B.S. or M.S. degree in Biotechnology (Biochemistry or Molecular, Viral and/or Cell Biology) Engineering, Computer Science or related technical field ASQ Certification is desirable Experience & Requirements: Minimum 5 – 7 years of experience working in a GMP Quality System within the Pharmaceutical or Biotech Industry Minimum 5 years of relative work experience in risk management, quality engineering, and/or qualification/validation preferably related to cell-based products Hands-on experience with statistical-based quality tools, including control charting, pareto analysis, histograms, correlation of causality. LEAN or Six Sigma tools, Kepner-Tregoe processes desirable Strong understanding of risk assessment and root cause analysis tools (fishbone diagrams, FMEA, 5 Why’s, etc.) Comprehensive expertise and working knowledge of GxP, Good Tissue Practices, 21 CFR Parts 11 compliance requirements, 21 CFR Parts 210/211/600/601/610, and ICH Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles Ability to identify and remediate process and system gaps