Environmental Monitoring Associate

4 weeks ago


Exton, United States Joulé Full time

Job Title: Environmental Monitoring Associate
Location: Exton, PA
Type: Contract to hire
Schedule: Monday - Friday 8am-5pm

Overview:
Cell and gene therapy company is looking for an experienced Quality Control- Environmental Monitoring Associate to join their team
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
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

Requirements: Minimum Bachelor of Science degree in a scientific discipline
Knowledge of Current Good Manufacturing Practice and Industry standards
Experience in a similar role in the biologics or pharmaceutical industry
Experience in aseptic processing and mammalian cell culture production
Familiarity of basic laboratory equipment such as microscopes, pH meters, incubators
Excellent verbal, written and organizational skills
Good interpersonal and communication skills
Must be open to occasional off shift and weekend work

#M3



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