Quality Control Engineer

Company Information

Castle Creek Biosciences is a late-stage biotechnology company developing re-dosable cell and gene therapies. It is conducting a pivotal Phase 3 clinical trial of its lead candidate for patients with dystrophic epidermolysis bullosa (DEB). Castle Creek, a Paragon Biosciences portfolio company, is headquartered in Exton, Pennsylvania with additional office space in Chicago, Illinois. Learn more at castlecreekbio.com.

Role Summary

Will support the Quality Control department in technical projects, equipment qualification, statistical analysis of test results, data trending and reporting, investigations, root cause analysis, and supplier qualification. Applies good engineering practices to meet regulations to support clinical and commercial requirements.

Responsibilities

• Tracks, trends, and reports on key quality performance indicators (KPIs), including out of specification results, analytical test results, and environmental monitoring results
• Lead and execute risk assessments, gap assessments, FMEA, root cause analysis, and continuous improvement plans to ensure product quality and regulatory compliance
• Write and/or review technical non-conformance and deviation reports 
• 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:
  1. Development of project design documentation
  2. Generating validation plans for equipment and test methods
  3. Compilation and review of validation protocols, executed data, and reports
  4. Execution of certain validation activities
  5. 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.
• Interprets 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. Participates 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.
• Train personnel on quality control procedures and best practices
• 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. degree in 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.