Sr. Quality Applications Engineer

Overview: Responsible for the development, implementation, maintenance, validation, and compliance of Quality Control computer systems and automated instruments within Andrx Pharmaceuticals. Establishes laboratory automation and validation strategy and implements tactical solutions to continuously improve efficiency, effectiveness, and compliance. Guide, lead, and support laboratory automation quality management principles and implement software quality programs and metrics to ensure laboratory automation meets business requirements with appropriate financial stewardship.Responsibilities:
Develops, modifies, applies, and maintains standards for departmental operating methods, processes, systems, and procedures.Develops, implements, maintains, and validates Laboratory Information Management System and other laboratory automation technical solutions. Manage projects and schedules on time and within budget. Provides quality and compliance solutions to project teams, Information Systems and outside contractors to support implementation of computer systems for automation and integration of Quality Control, Quality Assurance, scientific computation, data acquisition and processing.Support design, changes, and plans to meet laboratory process requirements. Train and support laboratory personnel in the use of laboratory automation.Perform root cause analysis and ensure corrective measures meet acceptable reliability standards, compliance, and business expectations and metrics.Job Requirements
Qualifications:
BS degree in Computer Science, Electrical Engineering, Science or Math.Seven years minimum experience working with validated computer systems within a cGMP environment.Three years minimum experience working with validated laboratory automation within a cGMP environment.Extensive knowledge and experience of laboratory automation systems and related cGMP, GLP and 21 CFR part 11 requirements for computer systems.Experience working with strategic Information Technology applications for the Quality Assurance of manufactured pharmaceutical products.Experience working with colleagues across all levels within an organization