GMP Environmental Monitoring Specialist

Abzena; Bristol Township (Bucks County); On-site; USD 60,000 - 90,000; Full time

Job summary

Abzena is seeking a QA Associate – Environmental Monitoring to join our team in Bucks County, PA. The role involves performing environmental monitoring sampling in classified areas, coordinating with Manufacturing, and ensuring data integrity and traceability across GMP processes.

You will support investigations of excursions, review monitoring data and trend reports, and assist in maintaining inspection readiness and accurate GMP documentation.

Qualifications

• Strong attention to detail with precise documentation and data handling.
• Effective written and verbal communication skills for cross-functional collaboration.
• Ability to work independently, manage multiple priorities, and perform under pressure.
• Experience performing or reviewing environmental monitoring sampling and data is preferred.

Responsibilities

• Performs routine and event-driven environmental monitoring sampling in classified areas, including viable and non-viable air, viable surface, personnel, as defined by procedures.
• Plans and coordinates sampling activities with Manufacturing and other site functions to ensure required monitoring is completed on schedule.
• Ensures samples are correctly identified, handled, transferred, and documented with complete chain of custody and traceability; coordinates lab testing.
• Escalates missed samples, excursions, and contamination-control concerns; supports investigations of alert and action level excursions and recurring signals.
• Reviews environmental monitoring forms for completeness and accuracy; prepares trend reports and site management review slides.

Skills

Attention to detail

Written communication

Verbal communication

Independent worker

Multi-tasking

Education

BS in Microbiology/Biology/Biochemistry/Chemistry

Tools

GMP Regulations Knowledge

21 CFR

GDP

US/EU/ROW Standards

Job description

Abzena is seeking a QA Associate – Environmental Monitoring to join our team in Bucks County, PA. The role involves performing environmental monitoring sampling in classified areas, coordinating with Manufacturing, and ensuring data integrity and traceability across GMP processes.

You will support investigations of excursions, review monitoring data and trend reports, and assist in maintaining inspection readiness and accurate GMP documentation.