What are the responsibilities and job description for the QC Analyst I position at Complete Staffing Solutions?
Quality Control Analyst I (Environmental Monitoring / QC Testing)
Key Responsibilities
Basic Requirements
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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.
Basic Requirements
- 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.
- Ability to lift up to 40 lbs.
- May require carrying a company-issued device for off-shift alerts.
- Must be able to gown into ISO 7 classified cleanroom areas.
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