What are the responsibilities and job description for the QC Microbiology Laboratory Specialist position at Comrise?
QC Microbiology Laboratory Specialist
Location: Mahwah, NJ
Duration: 12 Months
Schedule: Monday-Friday (8:00 AM-4:00 PM or 9:00 AM-5:00 PM)
Pay Rate: $45/hr
Position Summary
We are seeking a QC Microbiology Laboratory Specialist to support the manufacturing of orthopedic medical devices by ensuring compliance with sterilization, cleanliness, and microbiological quality standards. This role will perform routine microbiological testing, environmental monitoring, and laboratory analyses while maintaining compliance with cGMP, USP, ISO, and regulatory requirements.
The ideal candidate has hands-on QC microbiology laboratory experience, strong attention to detail, and experience working in a regulated laboratory environment.
Key Responsibilities
- Perform routine microbiological testing in accordance with approved procedures and regulatory requirements.
- Conduct environmental monitoring and water testing.
- Analyze environmental and water samples, including microorganism identification.
- Accurately document laboratory activities following Good Documentation Practices (GDP).
- Enter and trend laboratory data.
- Support review of laboratory worksheets and documentation.
- Assist with Out-of-Specification (OOS) investigations.
- Operate, calibrate, maintain, and troubleshoot laboratory equipment.
- Prepare laboratory solutions and reagents.
- Maintain laboratory inventory and ensure adequate supplies are available.
- Follow cGMP, laboratory safety, and quality procedures at all times.
Required Qualifications
- Bachelor's degree in Biology, Microbiology, Biological Sciences, or a related scientific discipline.
- Minimum of 2 years of Quality Control Microbiology laboratory experience.
- Knowledge of cGMP and compendial testing (USP/ISO).
- Experience with microbiological testing in a regulated environment.
- Strong documentation and data recording skills.
- Excellent verbal and written communication skills.
- Ability to work independently while managing multiple priorities.
- Strong attention to detail and manual dexterity.
Preferred Qualifications
- Medical device or pharmaceutical industry experience.
- Experience with:
- Sterilization processes
- Environmental Monitoring (EM)
- Aseptic techniques
- Microbiological Quality Control testing
- Water testing (e.g., Total Organic Carbon)
- Growth Promotion Testing
- Familiarity with OSHA laboratory safety practices.
Salary : $45