Cynet Systems

Conducts and manages resolution of deviations, root cause investigations, impact assessments and CAPAs as a Lead Investigator.. Proactively manages progression of investigation and CAPA to timely closure.. Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste. Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferred.. Prior experience in/Knowledge of cell culture, recovery, and purification biopharmaceutical manufacturing preferred.

compliance specialist

Job Description: Pay Range $49hr - $52hr Responsibilities: <ul><li> Conducts and manages resolution of deviations, root cause investigations, impact assessments and CAPAs as a Lead Investigator. </li><li> Liaises with many different groups/organizations as a Lead Investigator. </li><li> Proactively identifies and facilitates resolution of obstacles to timely completion. </li><li> Proactively manages progression of investigation and CAPA to timely closure. </li><li> Leads and participates in cross-functional investigation teams. </li><li> Presents investigation findings to key stakeholders and site management. </li><li> Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste </li> </ul> Knowledge and Skill: <ul><li> Required BS in chemical/biochemical engineering, biological sciences, or a related discipline with 1-3 years relevant experience. </li><li> Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferred. </li><li> Demonstrated basic project management skills(organization, collaboration, multi-tasking and communication),attention to detail, and the ability to perform well in a team-based environment are required. </li><li> Excellent verbal & written communications skills, including ability to present information clearly and concisely. </li><li> Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization. </li><li> Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment. </li><li> Prior experience in/Knowledge of cell culture, recovery, and purification biopharmaceutical manufacturing preferred. </li> </ul> Must Haves: <ul><li> 1-3 years of experience in investigations and a Bachelor's Degree.</li></ul>

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