Manufacturing Assurance Specialist

Investigate manufacturing deviations, environmental monitoring excursions, calibration investigations and summarize the information including determination of assignable cause and impact on the product and/ or production.

• Work closely with the Manufacturing, Quality Operations, Facilities, Quality Control and Quality Assurance departments on a daily basis and help resolve conflicting interests to reach a postive outcome.
• Perform thorough investigations, identify root causes and determine corrective actions.
• Perform Facility and Utility Area Inspections and report any findings with potential production impact to department and area manager.
• Generate formal written reports that summarize findings and corrective/ preventive measures to reduce the potential for recurence.
• Assist in CAPA generation, execution, implementation, DCM Submission, Plant change control or similar.
• Review manufacturing, Facilties, Environmental monitoring documentation and other documentation as needed to complete an investigation and summarize the findings.
• Maintain current knowledge of regulatory and industry standards
• Work and make decisions independently, with limited supervision.

• Previous experience with GMP manufacturing is required.
• Must have strong quality documentation skills.