Microbiologist II
Location: Monroe, NC
Responsibilities:
- Perform Microbiological testing and examination according to valid procedures; such as Bioburden, Endotoxin, Sterility, Growth Promotion, and Environmental Monitoring.
- Execute method validations for medical device and non-medical device for bioburden and sterilization according to ISO standards.
- Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
- Assist in the development of facility gowning program.
- Act as an SME for method validation for new products.
- Author SOPs, test procedures, and assist in creating validation protocols and reports for the lab.
- Data entry for trends and reporting on them for management review.
- Interpretation of sterilization dose audit results and elevation of the data trends as needed.
- Test non-conforming product to resolve QIR issues as well as investigate returned products via complaint processing system.
- Assist in investigations along with other departments to identify root cause.
- Completion of assigned CAPA as needed.
- Conduct aseptic technique training and Hygiene regulation training for other departments.
- Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
- Purchase requisition and material transfer in SAP.
- Coordination of sample testing via external/third-party vendor(s).
- Other duties as assigned.
Requirements:
- Minimum Bachelor's or Master's Degree in microbiology, or related field.
- 5 years of relevant work experience in GMP-controlled laboratory environment.
· Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred.
- Basic Knowledge of medical device regulation, industry, and international standards.
- Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).
- Knowledge of gamma and ebeam sterilization, and ISO 11137 requirements.