Sterility Assurance, Aseptic Process Monitor 1St Shift

Responsibilities may include:

• Ensures company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS)

• Schedule & Proctor Media Fills

• Observes technicians in compounding and routine clean room activities

• Reviews Environmental/Personnel monitoring data to identify any potential trends

• Providing qualification support for personnel on appropriate gowning techniques, aseptic techniques including execution of Compounder and MQA EM Specialist Competency Assessments as well as qualification support for clean room cleaning.

• Performs reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units

• Performs EM/PM sampling as needed

• Maintains EM/PM records

• Maintains Media Fill and Gown Qualification/Requalification records

• Provides support for sterility investigations including EM/PM excursions and review of deviations and investigations

• Assists in the generation of Sterility Assurance reports and documents

• Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function

• Works in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs)

• Supports department supervision in oversight and prioritization of day-to-day responsibilities.

• Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP

• Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes

• Evaluation of batches / product for compliance with defined specifications

• Other duties as assigned