Our client, a leading pharmaceutical company, is hiring a Compliance Specialist on a contract basis.
Devens, MA – 50% on-site
Manufacturing Compliance Associate Scientist
- Required BS in chemical/biochemical engineering, biological sciences, or a related discipline with 2 years relevant experience.
- 1 year of experience in investigations
- 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.
- 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.