Vertex
Boston, MA, USA
Job Description The GMP Quality Specialist supports the principles and application of quality assurance and regulatory compliance. The Specialist provides support and executes routine tasks related to GMP activities. Key Duties and Responsibilities: Participates in compliance related teams working towards the goal of continuous improvement. Provides QA support of change controls, GMP investigations and CAPAs. Responsible for generating performance metrics, trends Participates in the development of SOPs, protocols and reports Participates in continuous improvements of department processes. Participates in inspection readiness and support activities Knowledge and Skills: Knowledge of cGMP's in a pharmaceutical setting Ability to collaborate effectively within a team Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects Strong attention to detail Effective communication skills, both verbal and written....