Piper Companies is seeking a QC Microbiology Specialist to perform routine Environmental Monitoring sampling of the manufacturing facility for a Global Pharmaceutical Company in Raritan, NJ.
Responsibilities for the QC Microbiology Specialist included:
- Perform routine EM sampling related to clinical/commercial operations in a GMP environment
- Process transfer to cGMP facility to manufacture products
- Create, review, revise relevant QC documents, SOP's, Work Instructions
- Participate in training of Operations aseptic technique and microbiology awareness
- Utilize LIMS for execution and documentation of testing
Requirements for the QC Microbiology Specialist include:
- Bachelor's Degree in Science, Engineering
- Minimum 2 years experience working in biologic/Pharma industry
- Experience in QC setting
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required
- Knowledge of Good Tissue Practices is required.
- Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred
- This position may require occasional travel to partner sites in NJ or PA as business demands.
- This position may require up to 10% domestic or international travel as business demands.
Compensation for the QC Microbiology Specialist include:
- Pay rate is commensurate with experience