Quality Engineer

6/27/22

Bethlehem, PA

1737

1737: Quality Engineer

Essential Duties and Responsibilities

  • Define, draft, and or update, as necessary, metrics within quality and the supply chain as requested
  • Update procedures as necessary based on data from metrics program to reduce deviations and other investigation type documents
  • Partner with other departments as necessary and guide, mentor, and assist with continuous improvement initiatives
  • Work with Regulatory Affairs and other departments as necessary to ensure product approvals and launches are performed within required timeframes
  • To provide support and documentation as needed to meet compliance with global needs for our licensed products
  • Assist, as necessary with the validation and change control effort for the facility
  • To provide support and guidance to all departments regarding GMP requirements and issues for validation and change control projects
  • To manage competing priorities and provide adequate support and leadership to all team members and feedback on various tasks and projects
  • Determining quality improvement factors
  • Implementing methods to evaluate the reliability of manufacturing and packaging processes, products and production equipment
  • Making sure processes adhere to quality standards
  • Preparing reports by collecting, analyzing and summarizing data
  • Support Operations with troubleshooting of issues affecting product quality
  • Procedure updates
  • Support Regulatory Health Authority inspection and customer audits

Education / Experience

  • Bachelor degree or higher in relevant scientific/quality assurance/technical field
  • Total combined years of 5+ within pharmaceutical, biotechnology or similar industries
  • Strong understanding of pharmaceutical cGMPs, FDA and ICH quality guidelines (ICH Q7-10)
  • Experience developing metrics programs that drive continuous improvement using proven methods that reduce deviations, OOS, and other types of investigations that delay the supply chain
  • Knowledge and/or experience using Lean Six Sigma methods
  • Knowledge of Microsoft Office, QMS measurement systems such as Trackwise, and software systems that drive continuous improvement
  • The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manner

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