Compliance SpecialistLocation: 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 DegreeMajor Duties and Responsibilities:Conducts and manages resolution of deviations, root cause investigations, impact assessments and CAPAs as a Lead InvestigatorLiaises with many different groups/organizations as a Lead InvestigatorProactively identifies and facilitates resolution of obstacles to timely completionProactively manages progression of investigation and CAPA to timely closureLeads and participates in cross-functional investigation teamsPresents investigation findings to key stakeholders and site managementUses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate wasteKnowledge and Skill:Required BS in chemical/biochemical engineering, biological sciences, or a related discipline with 1-3 years relevant experiencePrior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferredDemonstrated 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 requiredExcellent verbal & written communications skills, including ability to present information clearly and conciselyExcellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organizationPrior experience with SOPs, cGMPs and the know how to work within a regulatory environmentPrior experience in/Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing