Senior Quality Assurance Specialist, Operations

Description

The QA Specialist works independently to provide quality assurance oversight of any area assigned where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including critical utilities, (e.g. Automation, equipment, HVAC, etc.), warehouse, distribution processes, inspection, labeling and packaging, batch disposition, new product introduction. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to processes, risk management, and ensuring documentation and investigations meet all requirements.

Key Responsibilities