QC Environmental Monitoring Associate [Contract]

Job Description

Job Description

General Responsibilities :

Performs environmental monitoring in support of aseptic product manufacturing.

Responsibilities :

• Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing and particulate monitoring
• Perform batch record verification of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed
• Perform Growth Promotion testing on prepared media
• Direct Sterile Media Fill Trials and perform support testing
• Maintain housekeeping in the Quality Control laboratories
• Assist the Quality Control department in daily operations, as needed
• Author and revise QC SOPs as necessary to maintain compliance
• Timely response to Out Of Specification (OOS) results, including notification to area supervision
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule
• Employment of myriad analytical equipment in support of product quality
• Training of other employees as necessary
• Completion of thorough Manufacturing Investigation Reports (MIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented

Computer Skills

Education :

Experience :