Location: Devens, MA
Start date: ASAP
Our client is looking for the following:
- Conducts and manages resolution of deviations, root cause investigations, impact assessments and CAPAs as a Lead Investigator
- Liaises with many different groups/organizations as a Lead Investigator
- Proactively identifies and facilitates resolution of obstacles to timely completion.
- Proactively manages progression of investigation and CAPA to timely closure.
- Leads and participates in cross-functional investigation teams.
- Presents investigation findings to key stakeholders and site management.
- Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
With the following credentials:
- Required BS in chemical/biochemical engineering, biological sciences, or a related discipline with 2-4 years relevant experience
- Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferred.
- 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
- Excellent verbal & written communications skills, including ability to present information clearly and concisely.
- Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization.
- Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment
- Prior experience in/Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred
System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.