Job Summary-
The QA Supervisor, Quality Systems and Compliance is responsible to lead and inspire a team of quality system professionals having oversight for maintaining and working with cross functional teams. This role encompasses the oversight in the areas of internal and client audit programs, supplier and material qualification programs, document control and training
Job Duties:
- Supervises QA personnel, including organizing and prioritizing group tasks
- Responsible for compliance relative to the overall Internal Audit Program and Supplier Qualification Programs
- Responsible for follow up and tracking of internal and supplier audit observations
- Monitor and communicate supplier change notifications
- Drafting, review and management of supplier quality assurance agreements (QAA's) and non-disclosure agreements
- Provides support during FDA and other regulatory agency inspections and support inspection readiness activities
- Writes and revises QA Standard Operating Procedures (SOP)
- Support continuous improvement initiatives
Experience:
- -3+ Years of experience in a Pharma, Biotech, or Med device manufacturing setting
- -Working Knowledge of FDA requirements