Sr Quality Assurance Specialist

We are looking for a Sr Quality Assurance Specialist to provide quality and technical support to the production team. The position involves reviewing and approving data and documentation, utilizing risk management, quality planning, and statistical analysis to complete assigned tasks.

Requirements

• Represent quality department on development project teams
• Review and approve product and process-related documentation
• Support the generation and justification of product and materials specifications
• Provide support for the development of validation strategies and validation plans
• Review/approve protocols and reports
• Support Deviation / CAPA investigations
• Support interdisciplinary teams for root cause analysis of quality deficits
• Support product quality and System improvements activities
• Support collection and analyze data to identify opportunities for quality improvement
• Work with multifunctional teams to drive resolution to product complaints
• Support to facilitate risk assessment activities such as design and process FMEA
• Ensure product risks are identified, and risk mitigation controls are put in place
• Provide real time production floor QA oversight
• Evaluate manufacturing data for trends and other special causes
• Review and disposition manufacturing / packaging batch documentation
• Perform room / line clearances as needed
• Review and disposition raw materials / components for manufacturing
• Support resolution of quality issues in manufacturing

Benefits

• performance-based remuneration
• occupational health benefits
• hybrid and flexible working environments