Quality Assurance Specialist

Responsibilities:

Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.

Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.

Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.

May also investigate and trouble-shoot problems which occur and determine solutions.

Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.

Maintains all documentation pertaining to validation.

Will assist in developing procedures and/or protocols.

Coordinates contract personnel through completion of assignments.

Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.

Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems.