Quality Control Environmental Monitoring Associate - Joule : Job Details

Quality Control Environmental Monitoring Associate

Joule

Job Location : Exton,PA, USA

Posted on : 2024-10-25T08:17:08Z

Job Description :
Job Title: QC Environmental Monitoring SpecialistWhile professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required. Location: Exton, Pa Type: 6-month Contract to Hire Schedule: Monday - Friday 8A-5P Responsibilities: Conduct viable and non-viable environmental monitoring in clean rooms (air, surface, personnel, particulate). Verify batch records for critical aseptic manufacturing steps. Perform Growth Promotion testing on prepared media. Direct Sterile Media Fill Trials and conduct support testing. Maintain QC laboratory housekeeping. Assist in daily QC operations. Author/revise QC SOPs to ensure compliance. Respond promptly to Out of Specification (OOS) results and notify supervisors. Coordinate with Operations (Manufacturing, QA, Facilities) to meet objectives. Use analytical equipment to support product quality. Train employees as needed. Complete thorough Manufacturing Investigation Reports (MIRs) to identify root causes, assess impact, and implement corrective actions. Requirements: Bachelor of Science in a scientific discipline. Knowledge of cGMP and industry standards. Experience in biologics/pharmaceuticals, especially in aseptic processing and mammalian cell culture. Familiarity with basic lab equipment (microscopes, pH meters, incubators). Strong verbal, written, and organizational skills. Good interpersonal and communication skills. Willingness to work occasional off-shift and weekends.
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