QA Associate - Environmental Monitoring

Abzena Inc. • Bristol, PA

8d

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 coordinates sample pickup and data-report receipt with a third-party laboratory. It also provides backup support to the Quality Operations Team, including batch record review, batch disposition activities, quality-on-the-floor oversight, and 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 sampling, according to approved procedures.
• Plan and coordinate sampling with Manufacturing and other site functions to complete required monitoring on schedule.
• Identify, handle, transfer, and document samples with complete chain of custody and traceability; coordinate pickup and testing with the 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 oversight, and monthly quality walkthroughs.
• Complete required training and maintain qualification for assigned duties.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level