The Quality Engineer must demonstrate a sound knowledge, application and proper implementation of technical, quality and scientific principals necessary to meet industry and customer requirements. The Quality Engineer has the primary responsibility providing Quality Assurance input to all aspects of quality systems including but not limited to Validation protocols and technical reports Preparation/review of protocols including complex systems such as Process Validation, computer controlled systems validation, complex utilities, complex manufacturing equipment such as filling systems, formulation systems and knowledge of laboratory validation.
Essential Duties and Responsibilities
- Works closely with other members of plant quality, manufacturing, calibration services and R&D organizations to accomplish overall objectives; and understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices that are current and ongoing at the manufacturing/packaging site
- Preparation/review of protocols including complex systems such as Process Validation, computer controlled systems validation, complex utilities, complex manufacturing equipment such as filling systems, formulation systems and knowledge of laboratory validation.
- Identify key quality issues and assist their resolution.
- Employ knowledge of process improvement techniques and tools such as the DMAIC model, FMEA, process Flow Diagram, Affinity Diagram, Pareto, Control Charts (SCP) Run Charts, SOP etc.
- Contribute to the APR Process, utilizing statistical tool
- Support the scheduling Annual Product Review process,
- Analyze data and statistical process control charts, if applicable, for active products
- Prepare quality related memorandums
- Draw conclusions regarding the products’ current state of control
- Initiate CAPA, change controls and/or NOEs, and make process recommendations, as required
- Revise/update APR related standard operating procedures (SOPs), as necessary, to reflect current practice and to conform to all applicable regulations
Qualifications and Requirements
- Minimum of 3-5 years in a pharmaceutical or manufacturing setting
- Bachelor’s degree in Engineering or Science related field required
- Master’s degree preferred
- Strong working knowledge of cGMP and Federal (FDA) requirements and guidelines
- Six Sigma Certified (Preferred)
- Strong technical writing skills and knowledge of Good Documentation Practices
- Strong knowledge of computer software including word processing, Excel, and PowerPoint
- Ability to interface senior level employees from multiple departments