Senior Microbiology QC Analyst (cGMP)

Replimune; Framingham (MA); Hybrid; USD 93,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Flexible time off

Paid holidays incl. year-end shutdown

Job summary

Replimune, located in Framingham, MA, is seeking a Senior QC Microbiology Analyst to lead setup and routine testing in the new QC Microbiology Laboratory. The role ensures GMP-compliant operations, environmental monitoring, and data review for bioburden, endotoxin, growth promotion, Gram stain, and species identifications.

The ideal candidate has 3–5 years of microbiology lab experience, strong technical microbiology skills, and proficiency with MS Word/Excel.

Qualifications

• Three to five years of Microbiology laboratory-based experience in a QC testing capacity.
• Excellent microbiological skills and technical experience is a must.
• Thorough understanding of industry testing requirements for QC Microbiology and experience of cGMP.
• Computer literacy (MS Word and Excel), good communication and organizational skills.
• Ability to work well independently and with others in a team.

Responsibilities

• Set up and maintain the QC microbiology laboratories and systems needed to enable testing requirements in support of the facility.
• Assist in scheduling and oversight of environmental monitoring testing performed in QC Microbiology laboratories.
• Execute the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.
• Perform routine QC Microbiology sampling and testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications.
• Perform water sampling and associated water testing (such as chemical analysis to include visual appearance, heavy metals, nitrates, pH, conductivity, etc.).
• Sampling and testing of gas supplies to manufacturing suites.
• Trend environmental monitoring data and compile trend reports.
• Write and revise SOPs, protocols and technical reports as necessary.
• Coordinate shipment of samples to contract testing laboratories and review of testing data reports.
• Review testing data of other QC Analysts, as applicable.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory and ordering of supplies, etc.
• Maintain QC Microbiology related systems in compliance with industry standards.

Skills

Microbiology experience

cGMP knowledge

Independent worker

Team collaboration

Communication skills

Education

BA/BS in Microbiology

Tools

MS Word

MS Excel

Job description

Replimune, located in Framingham, MA, is seeking a Senior QC Microbiology Analyst to lead setup and routine testing in the new QC Microbiology Laboratory. The role ensures GMP-compliant operations, environmental monitoring, and data review for bioburden, endotoxin, growth promotion, Gram stain, and species identifications.

The ideal candidate has 3–5 years of microbiology lab experience, strong technical microbiology skills, and proficiency with MS Word/Excel.