Job Information
System One Environmental Monitoring Associate in Exton, Pennsylvania
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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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