Quality Engineer
Job Type:
Regular Full-Time
Location:
Morris Plains, NJ
Job Description:
Dendreon is looking for a Quality Engineer, who will provide leadership and support for the implementation of Quality Engineering policies and procedures in support of commercial manufacturing at our New Jersey facility. The successful candidate will have the opportunity to develop and implement a Manufacturing Process Monitoring program and a Quality By Design program. This new position is a great fit for someone who enjoys thinking outside the box, using their communication skills to influence new ways of working, and validating best practices.
General Summary:
Provides support in the identification and statistical analysis of operation performance metrics.
Provides DOE support for process characterization and analytical development activities.
Utilizes quality engineering tools such as FMEA and process mapping in support for investigations, deviations, non-conformances, OOS and corrective actions.
Provides support for investigations associated with product failures, product complaints and BPDRs.
Tracks and trendsmetrics in support of management review.
Participates in the development and generation of the Annual Product Review.
Develops program to facilitate rational decision making.
Requirements:
Bachelor’s degree in science, engineering, math or equivalent.
Typically 5 years related experience in quality assurance, quality control, quality engineering, or manufacturing of commercial pharmaceutical or biotechnology derived parenteral and/or cellular therapies preferred.
Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.
Proficient in MS Office applications.
Experience with SAS and/or Jump preferred.
Working Conditions and Physical Requirements:
Ability to gown aseptically for work in Clean Room environments.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.