Job Description

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 monitoring
• Maintain accurate training records and adhere to testing schedules to meet project timelines
• Assist with laboratory equipment maintenance and inventory management
• Submit data promptly; may serve as a data reviewer to ensure timely availability
• Execute operational tasks including environmental monitoring, utility sampling, and product testing
• Contribute to the revision of SOPs, work instructions, and test methods for continuous improvement
• Ensure compliance with internal policies and external regulatory standards (GMP, GLP, ICH)
• Collaborate with cross-functional teams to support QC operations and company objectives
• Participate in inspection readiness activities and support audits as needed
• Support quality events such as investigations, deviations, CAPAs, and change controls
• Engage in initiatives to improve QC processes and laboratory efficiency

Qualifications

• 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 industry
• Demonstrated experience in microbiology testing and environmental/utility sampling
• Familiarity with quality event documentation preferred
• Experience with data analysis and trending preferred
• Strong attention to detail and ability to adapt to shifting priorities
• Effective communicator and team collaborator
• Proficiency with LIMS, Microsoft Excel, Word, and PowerPoint

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