Production - COMPLIANCE SPECIALIST

Co mpliance 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

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