Supervisor, Quality Record Review 2Nd Shift

Responsibilities may include:

• Responsible for timely and accurate review and completion of finished product and intermediate batch records to assure each batch meets quality standards and specification prior to release

• Supervises Quality Assurance staff on assigned shift

• Responsible for maintaining QA records including but not limited to Batch Records, Log Books and all other relevant records.

• Track and trend and report on department performance KPI's associated with record review metrics.

• Provide support during internal/external audit-related activities.

• Supports failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions

• Supports to identification and implementation of appropriate corrective actions and preventive actions

• Supports the environmental monitoring program including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results.

• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws

• Responsible to maintain applicable testing equipment in compliance, calibration, and certification

• Assists in developing policies and procedures related to QA

• Promptly communicates with Operations regarding complaints, product issues/variance

• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation

• Enforces applicable personnel policies and procedures

• Other duties as assigned