Conduct audits of (a) EWs internal clinical processes (b) clinical sites and (c) vendor audits with increased complexity and volume. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings. Evaluate the appropriateness and effectiveness of previous corrective actions, Develop and execute audit plans and schedules for compliance audits of assigned clinical study projects.
Developing and writing responses to customers for product complaints. Take complex medical procedure information and determine the course of events related to each complaint and write investigation findings in response to customer inquiries.
The Principal Clinical Quality Control Specialist works without appreciable direction and exercises considerable latitude in determining objectives of assignment(s) and compliance-oriented solutions to a wide range of complex scenarios.
Manage external documents and web-based subscription services including standards, specifications and technical papers required by the business. Status and maintain current specifications and post change announcements as required. Procure and fulfill request for various industry standards and specifications as new documents are required.
The Quality Assurance Specialist will be responsible for Quality Assurance on the floor duties including guidance on manufacturing quality concerns, bulk drug substance batch review, raw material review, cross-functional improvement projects, and writing /revising SOPs .
Quality systems support may include, but is not limited to, ensuring the proper documentation, investigation, impact and risk assessments, corrective / preventive action plans, monitoring and trending for the following quality systems.
Audit Food Safety and Quality records (Internally generated or from external sources), report findings and initiate corrective actions; assist during Internal, regulatory, customer, and third party audits .
Characterizes and drives improvement in products and services through systematic review of customer complaints and requests. Communicate with field service engineers and other sales staff on technical aspects of products and issue resolution.