QA Specialist – Environmental Monitoring (GMP)

Abzena Inc.; Bristol Township (Bucks County); Sur place; USD 65 000 - 95 000; Plein temps

Résumé du poste

Abzena is seeking an QA Associate – Environmental Monitoring to join our team in the United States. You will perform environmental monitoring sampling in classified areas, coordinate with Manufacturing and third-party labs, and assist with trending data and investigations.

The role supports GMP documentation, batch record review, and quality on the floor with escalation of any compliance concerns, ensuring inspection readiness and continuous improvement.

Qualifications

• 2–5 years of relevant GMP-regulated biopharmaceutical experience.
• BS in a related scientific discipline or equivalent experience.
• Working knowledge of GMP regulations (US, EU, ROW), GDP, 21 CFR, USP.
• Strong attention to detail and effective written and verbal communication.
• Ability to work independently, manage priorities, and perform under pressure.
• Experience in environmental monitoring sampling and data review is preferred.

Responsabilités

• Performs routine and event-driven environmental monitoring sampling in classified areas, including viable and non-viable air, viable surface, and personnel.
• Plans and coordinates sampling activities with Manufacturing and site functions to meet schedules.
• Ensures samples are correctly identified, handled, transferred, and documented with chain of custody; coordinates third-party lab testing.
• Escalates issues, supports investigations of excursions, and reviews adverse trends.
• Reviews environmental monitoring forms for completeness and compliance; prepares trend reports.
• Prepares content for monthly site management review slides summarizing metrics and risks.
• Supports Quality Ops with batch record reviews, disposition activities, and quality walk-throughs.
• Completes required training and maintains qualifications.

Connaissances

GMP knowledge

Analytical thinking

Excellent communication

Independent worker

Formation

BS in Microbiology/Biology/Biochemistry/Chemistry

Outils

LIMS

Description du poste

Abzena is seeking an QA Associate – Environmental Monitoring to join our team in the United States. You will perform environmental monitoring sampling in classified areas, coordinate with Manufacturing and third-party labs, and assist with trending data and investigations.

The role supports GMP documentation, batch record review, and quality on the floor with escalation of any compliance concerns, ensuring inspection readiness and continuous improvement.