What are the responsibilities and job description for the Quality Control Microbiologist position at United Pharma?
Quality Control Microbiologist (Medical Devices / Pharma)
Location: Boston, MA
Employment Type: W2 Only
About the Role
We are seeking a detail-oriented and experienced Quality Control Microbiologist to support microbiological testing and quality assurance activities within a regulated medical device/pharmaceutical manufacturing environment.
This role is critical in ensuring product safety, sterility assurance, and compliance with regulatory standards. The ideal candidate will have strong hands-on experience in microbiological testing, environmental monitoring, and aseptic practices.
Key Responsibilities
- Perform routine microbiological testing including bioburden, endotoxin, and sterility testing
- Conduct environmental monitoring (EM) for cleanrooms (air, surface, personnel monitoring)
- Analyze test data and ensure compliance with specifications and regulatory requirements
- Support method validation and method transfers
- Investigate out-of-specification (OOS) and out-of-trend (OOT) results
- Maintain accurate documentation in compliance with GDP (Good Documentation Practices)
- Assist in CAPA investigations and root cause analysis
- Ensure compliance with cGMP, FDA, and ISO standards
- Support audits and inspections by regulatory authorities
- Maintain and calibrate microbiology lab equipment
Required Qualifications
- Bachelor’s degree in Microbiology, Biology, or related life sciences field
- 3–7 years of experience in QC Microbiology (pharma or medical devices)
- Strong knowledge of aseptic techniques and cleanroom practices
- Hands-on experience with EM, sterility, bioburden, and endotoxin testing
- Familiarity with cGMP, FDA regulations, and ISO standards
- Experience handling OOS/OOT investigations
- Strong documentation and data integrity practices
Preferred Qualifications
- Experience in medical device sterilization processes
- Knowledge of LAL testing (Endotoxin)
- Exposure to method validation and transfer activities
- Experience with trackwise/deviation systems
Why Join Us?
- Work in a highly regulated and impactful industry
- Opportunity to grow within quality and microbiology functions
- Collaborative and quality-driven team environment