Position : Microbiology Analyst II – Quality Control Operations
Location : Onsite in Norton, MA (occasional travel to Cambridge, MA)
Employment Type : Contract
Pay Rate : $38 / hour
Position Overview
We are seeking a detail-oriented and experienced Microbiology Analyst II to support Quality Control Operations in a regulated pharmaceutical / biotech environment. This role is critical to maintaining high standards of quality and compliance from development through commercialization. The Analyst will perform microbiological testing, support laboratory operations, and contribute to quality event documentation and continuous improvement initiatives.
Key Must-Haves
- Hands-on experience with microbiology methods : bioburden, TOC, endotoxin, conductivity
- Environmental monitoring and critical utility sampling (e.g., water systems, compressed gas)
- Familiarity with trend reporting and quality events (investigations, deviations, CAPAs, change controls)
Key Responsibilities
Perform routine and non-routine microbiological assays to support product release, in-process samples, and utility monitoringMaintain accurate training records and adhere to testing schedules to meet project timelinesAssist with laboratory equipment maintenance and inventory managementSubmit data promptly; may serve as a data reviewer to ensure timely availabilityExecute operational tasks including environmental monitoring, utility sampling, and product testingContribute to the revision of SOPs, work instructions, and test methods for continuous improvementEnsure compliance with internal policies and external regulatory standards (GMP, GLP, ICH)Collaborate with cross-functional teams to support QC operations and company objectivesParticipate in inspection readiness activities and support audits as neededSupport quality events such as investigations, deviations, CAPAs, and change controlsEngage in initiatives to improve QC processes and laboratory efficiencyQualifications
B.S. in Biology, Biochemistry, Chemistry, or related field (Associate’s degree or Biotech Certificate considered)Minimum 2 years of experience in a regulated QC laboratory within the pharmaceutical / biotech industryDemonstrated experience in microbiology testing and environmental / utility samplingFamiliarity with quality event documentation preferredExperience with data analysis and trending preferredStrong attention to detail and ability to adapt to shifting prioritiesEffective communicator and team collaboratorProficiency with LIMS, Microsoft Excel, Word, and PowerPoint