Environmental Monitoring Associate from Joulé
Exton, PA
About the Job
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:
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!
- 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
- 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
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