Quality Control Environmental Monitoring Associate from Joulé
Exton, PA
About the Job
Job Title: QC Environmental Monitoring Specialist
Location: Exton, Pa
Type: 6-month Contract to Hire
Schedule: Monday - Friday 8A-5P
Responsibilities:
Requirements:
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.
