Environmental Monitoring Associate

4 weeks ago

Exton, United States System One Holdings, LLC 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 teamResponsibilities: 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 monitoringPerform batch record verification of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performedPerform Growth Promotion testing on prepared mediaDirect Sterile Media Fill Trials and perform support testingMaintain housekeeping in the Quality Control laboratoriesAssist the Quality Control department in daily operations, as neededAuthor and revise QC SOPs as necessary to maintain complianceTimely response to Out Of Specification (OOS) results, including notification to area supervisionCommunicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on scheduleEmployment of myriad analytical equipment in support of product qualityCompletion 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 disciplineKnowledge of Current Good Manufacturing Practice and Industry standardsExperience in a similar role in the biologics or pharmaceutical industryExperience in aseptic processing and mammalian cell culture productionFamiliarity of basic laboratory equipment such as microscopes, pH meters, incubatorsExcellent verbal, written and organizational skillsGood interpersonal and communication skillsMust be open to occasional off shift and weekend work #M3

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