Quality Engineer
Date Posted
6/27/22
Location
Bethlehem, PA
Position Id
1737
Degree Required
Job Type
Job Description
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