Edison Pharmaceuticals, Inc.
The Director of Quality Assurance will provide hands-on leadership for coordinating and managing the day-to-day activities of the Quality Assurance department as the QA organization moves from clinical GMP manufacturing, through validation,...
Adult Feminine Care Product Supply Quality Jobs / Neenah, WI Jobs at Kimberly-Clark
This AFC Product Supply Quality role is responsible for the leadership of a team which provides high level quality and regulatory support to manufacturing facility,...
Technical Resources International Inc.
Promotes Quality by preparing Standard Operating Procedures, providing training to staff and supporting the Quality Management System. Provides administrative support within TrackWise and serves as a system administrator. Responsibilities may also...
Location: Cambridge MA
Akebia Therapeutics is looking for an experienced GCP Auditor. The position will be responsible to assess compliance with Akebia standard operating procedures, ICH and US FDA regulations and guidelines, and...
Manages/organizes all lab operations and supports tasks pertaining to company research and development activities. Specific responsibilities include:
• Oversee facility activities to monitor compliance to regulations,...
• Compliance with safety guidelines
• May perform lot file review, which will include batch records and associated documentation
Identify documentation and procedural errors
Communicate errors noted to operations staff
Notify client of deviations...
Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer,...
Responsibilities of the Specialist, QA Operations will include, but are not limited to:
• Support manufacturing batch record review and disposition activities for starting materials, drug substances (API), drug products, and finished packaged...
ARK Diagnostics, Inc.
Responsible for the following areas:
document control, design control, manufacturing batch record review, validation, preventive maintenance/calibration program for equipment, internal audits, safety, CAPA and maintenance of the quality management...
The Director of Quality Assurance will report to the Sr. Director, Quality Assurance. This position will be responsible for quality and regulatory compliance of GMP and will assure the quality aspects of clinical and commercial drug substance/drug...