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:
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.
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
Education
Experience & Requirements