QC Micro EM Analyst I

Katalyst CRO; Walkersville (MD); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst CRO seeks a QC Environmental Monitoring Analyst to support cleanroom operations with routine environmental monitoring, microbiological testing, and lab maintenance. You will ensure GMP compliance and contribute to investigations of environmental excursions.

Responsibilities include performing environmental monitoring in cleanrooms, conducting microbiological tests, maintaining equipment, preparing data summaries and reports, and updating SOPs.

Qualifications

• BS degree preferred in Microbiology, Biology, Biotechnology or related field.
• 13 years' experience in environmental monitoring or microbiology.
• Experience in GMP/cleanroom environments preferred.

Responsibilities

• Perform environmental monitoring in cleanrooms (At Rest & In Operation).
• Conduct microbiological tests for media, raw materials, and product release.
• Perform microbial isolations and identifications.
• Support environmental investigations and write excursion/deviation reports.
• Maintain lab equipment, supplies, and general lab upkeep.
• Prepare data summaries, trend reports, and documentation.
• Write and revise SOPs and qualification reports.
• Maintain training compliance and assist in training new analysts.

Education

BS degree in Microbiology/Biology/Biotechnology or related field

Tools

GMP

Job description

Job Description

The QC Environmental Monitoring Analyst supports cleanroom operations by performing routine environmental monitoring, microbiological testing, documentation, and lab maintenance. This role ensures compliance with GMP standards and supports investigations related to environmental excursions.

• Perform environmental monitoring in cleanrooms (At Rest & In Operation).
• Conduct microbiological tests for media, raw materials, and product release.
• Perform microbial isolations and identifications.
• Support environmental investigations and write excursion/deviation reports.
• Maintain lab equipment, supplies, and general lab upkeep.
• Prepare data summaries, trend reports, and documentation.
• Write and revise SOPs and qualification reports.
• Maintain training compliance and assist in training new analysts.

Job Description

The QC Environmental Monitoring Analyst supports cleanroom operations by performing routine environmental monitoring, microbiological testing, documentation, and lab maintenance. This role ensures compliance with GMP standards and supports investigations related to environmental excursions.

Roles & Responsibilities

• Perform environmental monitoring in cleanrooms (At Rest & In Operation).
• Conduct microbiological tests for media, raw materials, and product release.
• Perform microbial isolations and identifications.
• Support environmental investigations and write excursion/deviation reports.
• Maintain lab equipment, supplies, and general lab upkeep.
• Prepare data summaries, trend reports, and documentation.
• Write and revise SOPs and qualification reports.
• Maintain training compliance and assist in training new analysts.

Requirements

• BS degree preferred (Microbiology, Biology, Biotechnology, or related field).
• Degree not required if candidate has relevant experience.
• 13 years' experience in environmental monitoring or microbiology.
• Experience in GMP/cleanroom environments preferred.

Additional Requirements

• 100% onsite role.
• Work hours: 7/8 AM 5 PM (flexibility required).
• Gowning training provided.
• Ability to lift up to 50 lbs.
• Must be comfortable using stairs, ladders, and step stools .