QA Associate - Environmental Monitoring

Abzena•Bristol, PA

About The Position

The QA Associate – Environmental Monitoring performs and coordinates environmental monitoring sampling, evaluates and trends monitoring data, and prepares periodic trend reports. The role works closely with a third-party laboratory to arrange sample pickup and track receipt of data reports. It also provides backup support to the Quality Operations Team, including manufacturing support, batch record review, batch disposition activities, quality-on-the-floor oversight, and timely escalation of quality and compliance concerns. The associate works cross-functionally to maintain inspection readiness, ensure accurate GMP documentation, and support contamination control and continuous improvement.

Requirements

Bachelor of Science in Microbiology, Biology, Biochemistry, Chemistry, or a related scientific discipline; equivalent relevant experience may be considered.
2–5 years of relevant experience in a GMP-regulated biopharmaceutical environment.
Working knowledge of GMP regulations (US, EU, and ROW), GDP, 21 CFR, USP, and applicable standards.
Strong attention to detail and effective written and verbal communication skills.
Ability to work independently, manage multiple priorities, and perform under pressure.

Nice To Haves

Experience performing or reviewing environmental monitoring sampling and data.

Responsibilities

Perform routine and event-driven environmental monitoring sampling in classified areas, including viable and non-viable air, viable surface, and personnel monitoring, as defined by approved procedures.
Plan and coordinate sampling activities with Manufacturing and other site functions to ensure required monitoring is completed on schedule.
Ensure samples are correctly identified, handled, transferred, and documented with complete chain of custody and traceability.
Coordinate sample pickup and testing with a third-party laboratory.
Escalate missed samples, adverse conditions, excursions, and other potential contamination-control concerns as required.
Support investigations of alert and action level excursions, atypical results, and recurring contamination signals.
Review environmental monitoring forms for completeness, accuracy, specification compliance, and emerging adverse trends.
Prepare periodic environmental monitoring trend reports summarizing results, excursions, recurring observations, and recommended follow-up actions.
Prepare environmental monitoring content for monthly site management review slides, summarizing key metrics, trends, excursions, investigations, and risks.
Support the Quality Operations Team with executed batch record review, batch disposition activities, quality-on-the-floor work, and monthly quality walkthroughs.
Complete required training and maintain qualification for assigned duties.