Quality Control Analyst I (Environmental Monitoring / QC Testing)

Key Responsibilities

Perform environmental monitoring (EM) in classified cleanroom areas (ISO 7), including air, surface, and personnel monitoring.
Conduct QC testing using standard laboratory equipment (balances, pipettes, pH meters, UV/Vis spectrophotometers, plate readers, etc.).
Execute microbiological assays, bioburden testing, microbial limits testing, and microorganism identification and trending.
Support utilities testing and cleanroom compliance activities.
Perform cell culture–based microbial or molecular assays as needed.
Maintain, calibrate, and troubleshoot general QC laboratory equipment.
Document results in accordance with cGMP, SOPs, and data integrity standards.
Report OOS/OOT results promptly and support associated investigations.
Assist with method transfers, equipment qualifications, and audit readiness activities.
Participate in documentation updates, including SOPs, forms, and protocols.
Support routine laboratory operations such as glassware washing, autoclaving, inventory, and housekeeping.
Collaborate cross-functionally to resolve technical or testing-related issues.
Perform additional QC tasks as assigned.

High school diploma with 4+ years of experience in a cGMP laboratory environment, OR
AS degree in microbiology, biochemistry, molecular biology, or a related field with 2–4 years of experience, OR
BS degree in a relevant scientific discipline with 0–2 years of industry experience.
Hands-on environmental monitoring experience is required or strongly preferred.

Experience in microbiological testing in a regulated pharmaceutical or biotechnology environment.
Familiarity with LIMS, electronic documentation systems, and standard software such as MS Word, Excel, and Outlook.
Experience working in cleanroom environments.

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