Senior Quality Assurance Associate

Assist Manager, Quality Assurance in the design, implementation and continuous improvement of the company’s quality systems to ensure compliance with current Good Manufacturing Practices (CGMP), regulatory agencies, client and corporate expectations.

JOB RESPONSIBILITIES

• Assist in developing and managing company’s quality systems, CGMP compliance and continuous quality improvement projects
• Oversee and communicate daily priorities and scheduling of QA activities in coordination with other departments (operations, laboratories, supply chain, etc.)
• Review and approve quality related documents, such as equipment (IQ/OQ), process, computerized systems, analytical methods validations, stability protocols and reports, master batch records and executed batch records
• Review and approve intermediates, in-process controls and cleaning specifications
• Prepare, facilitate and respond to audits (regulatory agencies, client and/or i...