Sr Clinical Quality Specialist (Northridge, CA)
Medtronic
- Northridge, CA
- Permanent
- Full-time
- Execute Clinical Operations Quality strategies
- Inspection coordination, documentation, tracking, trending, analysis
- Audit coordination, documentation, tracking, trending, analysis
- CAPA coordination, documentation, tracking, trending, analysis
- Regulation and policy review, gap analysis, implementation, tracking
- Execute Management review and reporting
- quality metric development, collection, analysis, trending, and tracking
- other management review function integration (e.g., supply chain)
- Advises on clinical quality assurance, review and prepare clinical study documentation for inspections
- Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures.
- Coordinate support for study teams to ensure successful audit and inspection activity consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements, based on location of study conduct
- Develop Quality processes to comply with applicable regulations, guidances and policies
- Provide training on GCP and current regulations for those undertaking clinical studies
- Support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.
- Attend and support clinical study meetings and Operations meetings (e.g., meeting facilitation, minutes, action item follow-up, arrangements, ad hoc assignments)
- Support development/revision and implementation of procedures aligned with relevant global regulations and standards
- Determine obstacles, identify solutions, and implement plans in collaboration with management to meet study objectives, scope and schedules
- Bachelor’s degree and 4 years of work experience in clinical/clinical research within healthcare industry (i.e., medical device, biotech, pharmaceutical)
- or, Master’s degree and 2 year of work experience in clinical / clinical research within healthcare industry (i.e. medical device, biotech, pharmaceutical)
- Experience with Quality-related projects/tasks (i.e. audit, reviews, clinical quality operations)
- Experience in medical device clinical trials/clinical trial setting
- Familiarity of Operations and Quality processes
- Experience in Project management and database systems (e.g., MS Project, Access, CTMS, SAP, Agile, Trackwise)
- Proficiency in word processing, spreadsheets applications (e.g., MS Word and Excel)
- Strong verbal and written communication skills, technical and problem solving skills
- Able to read, analyze and interpret general business documents, technical procedures, and specifications
- Able to write reports, business correspondence and procedure manuals effectively
- Able to work effectively, independently and on cross-functional teams
- Able to frequently use general knowledge of industry regulations, practices, techniques, and standards
- Develops solutions to a variety of problems of moderate scope and complexity
- Willing to be flexible with work hours
- Posting Date: Apr 8, 2024
- Travel: Yes,
- Salary Min: 94,400
- Salary Max: 141,600