Quality Assurance Associate responsibilities include:Review protocols, procedures, data, reports, and other documentation for internal accuracy, consistency, and conformance with GLP regulations.Files protocols, amendments, deviations, inspections and other quality documents appropriately.Prepares, issues, and tracks reports of observations noted during audits and inspections.  Reviews and evaluates addressed deficiencies for clarity, completeness, correctness, and potential impact on compliance status.Perform phase inspections of ongoing studies.Perform facility audits to ensure departmental compliance with the regulations.Works with staff, study directors, principal investigators, and management to detect and resolve any quality issues.Maintains computerized files to support audit activities.Maintains Master Schedule in accordance with specified regulations and standard operating procedures.Reviews equipment calibrations, qualifications, and validations for adherence to company procedures (e.g., SOPs) and federal regulations.Assists with implementation and monitoring of quality systems and procedures (e.g., CAPA, Metrics, Change Control, Training, etc.).
