CELL THERAPY QUALITY ASSURANCE ENGINEER
DiscGenics is a clinical-stage biotechnology company that is developing and commercializing a patented injectable disc cell therapy product that will alleviate pain and restore function in patients suffering from degenerative diseases of the spine. We are looking for motivated and talented individuals to embark on this exciting endeavor with us as we develop our Quality Management System and scale-up operations in our new production facility.
We are seeking an independently-driven Cell Therapy QA Engineer capable of developing and implementing Quality Management Systems (QMS) that are compliant with applicable U.S. and international regulations. The quality assurance engineer will also support new product and process development efforts.
· Defines and implements Quality Management System processes in accordance with applicable U.S. and international tissue and pharmaceutical regulations including 21 CFR 210/211, 21 CFR 1270, PMDA regulations, including document control, change management, training, supplier quality, NCR/CAPA, internal audits, supplier quality, etc.
· Works intensively in and develops expertise in the electronic Quality Management System to aid in implementation of electronically-based quality systems.
· Creates QMS policies, Standard Operating Procedures, forms and templates.
· Manages contractors and consultants in support of DiscGenics’ QMS development activities as well as activities necessary to maintain QMS compliance (metric trending, supplier qualification, internal audits, design documentation, risk management, etc.)
· Leverages industry expertise and experience to guide and mentor company personnel through GMP/QMS requirements.
· Creates and executes training content for Quality systems.
- Approves validation documentation such as protocols and reports (URS, DQ, IQ, OQ, PQ, PV, CV).
· Serves as the voice of quality during the product design and development process. Works with product development personnel and SMEs to create design dossier documentation.
- In-depth knowledge of US FDA 21 CFR Parts 210/211, 820, and 1270
- Prior experience with electronic QMS software, Document Management Systems, Learning or Training Management Systems, and/or CAPA software.
- Proficient with Microsoft Office, including Word, Excel and PowerPoint
· Capable of creating process flow diagrams to develop and define quality systems.
· Strong technical writing skills and prior experience authoring policies and SOPs.
· Ability to educate, train, and influence people to achieve regulatory compliance.
· Committed to a team-oriented approach and collaborates with colleagues to achieve company objectives.
· Ability to work well independently, to multi-task, and to efficiently manage multiple, diverse projects simultaneously.
· Prior experience in root cause analysis and use of problem-solving tools.
· Familiarity with quality by design, design controls and risk management requirements a plus.
- Bachelor’s degree in a scientific field.
· Minimum of 5 years quality engineering experience in life science industry, biologics experience preferred.
· Prior experience working in a cGMP manufacturing environment.