Job Description: JOB TITLE: Manufacturing Compliance Associate Scientist
*This role will be a hybrid role, minimum 50% of the time on site
**Looking for 1-4 years of experience in investigations
Major Duties and Responsibilities:
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
Knowledge and Skill:
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
Additional Job Requirements:
None •
Last updated on Aug 14, 2023