Production - COMPLIANCE SPECIALIST

Location: Devens, MA Local Candidates Only *There are 2 openings for this role*

Top Must Haves: 1-3 years of experience in investigations and a Bachelor's Degree

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 1-3 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