QC Lab Analyst II - Cleanroom & Microbiology

Repligen Corporation; Marlborough (MA); On-site; USD 43,000 - 52,000; Full time

Job summary

Repligen Corporation in Marlborough, MA is seeking a Quality Control Analyst II to support environmental monitoring, RODI water sampling, and QC testing within ISO-classified cleanrooms. The role reports to the Quality Control Manager and requires meticulous documentation and adherence to SOPs and ISO 9001 standards.

Responsibilities include environmental data collection, routine QC assays (pH, conductivity, endotoxin, bioburden), trend evaluations, and investigations.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry or related scientific discipline.
• 2+ years of Quality Control laboratory experience or equivalent.
• Experience in ISO-classified cleanroom environments and GMP/ISO standards.

Responsibilities

• Perform environmental monitoring of ISO-classified cleanrooms and controlled environments, including data collection and trend analysis.
• Collect and test RODI water samples per approved procedures.
• Conduct routine QC testing (pH, conductivity, endotoxin, bioburden) and related assays.
• Document results accurately and maintain controlled records per SOPs and GMP practices.
• Support deviations, out-of-spec results, excursions, investigations, and trend evaluations as needed.
• Review peer documentation and data for completeness and compliance.
• Assist in SOP creation, revision, and implementation of lab procedures.

Skills

Environmental monitoring

Documentation

Aseptic technique

Attention to detail

Independent worker

Education

Bachelor's degree in Biology, Microbiology, Chemistry

Tools

SAP

CaneaOne

Job description

Repligen Corporation in Marlborough, MA is seeking a Quality Control Analyst II to support environmental monitoring, RODI water sampling, and QC testing within ISO-classified cleanrooms. The role reports to the Quality Control Manager and requires meticulous documentation and adherence to SOPs and ISO 9001 standards.

Responsibilities include environmental data collection, routine QC assays (pH, conductivity, endotoxin, bioburden), trend evaluations, and investigations.