Microbiology Analyst - Trend Reporting/Excursion InvestigationAdvantage Technical • Norton, MA, United States

Microbiology Analyst - Trend Reporting / Excursion Investigation

Advantage Technical • Norton, MA, United States

1 day ago

Job type

Full-time

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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Analyst • Norton, MA, United States

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