This role is a Specialist in the Devens Quality Assurance (QA) Technical Operations function. The role primarily supports the site-wide Investigations and Corrective Action/Preventative Action (CAPA) programs, inclusive of commercial drug substance manufacturing, clinical drug substance manufacturing, GMP cell banking, and Quality Control (QC) lab operations.
• Works cross-functionally with lead investigators, subject matter experts, and supervisors within the GMP functions to support investigations and CAPAs at the Devens site
• Provides oversight and guidance for deviation assessment, impact assessment, root cause analysis and CAPA planning activities
• Performs review and approval of investigations, CAPAs, and effectiveness reviews in the Quality Management System
Key Core behavioral indicators for this role include: Participates in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals. Demonstrates appropriate examples of compliance behaviors and attitudes. A high degree of accountability and matrix leadership is critical.
Knowledge and Skill set Requisites:
• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.
• A minimum of 4 years relevant experience with a minimum of2 years in a regulated environment.
• Knowledge of Investigations and/or CAPAs is highly desirable.
• Knowledge of biotech bulk and finished product manufacturing, and/or analytical testing, is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva, and electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well practiced in exercising sound judgment in decision-making.
• Past experience where one was required to work in a team based environment with a diverse group of people.