About the role
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The QA Associate – Environmental Monitoring is responsible for performing and coordinating environmental monitoring sampling, evaluating and trending environmental monitoring data, and preparing periodic trend reports. This role will work closely with the third-party lab to arrange sample pick up and track receipt of data reports.
This role will provide back-up assistance to the Quality Operations Team to support manufacturing, including 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 effective contamination control and continuous improvement.
Responsibilities
Performs routine and event-driven environmental monitoring sampling in classified areas, including viable and non-viable air, viable surface, personnel, as defined by approved 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 pick up and testing with third-party lab. Escalates missed samples, adverse conditions, excursions, and other potential contamination-control concerns, as required. Supports investigations of alert and action level excursions, atypical results, and recurring contamination signals. Reviews environmental monitoring forms for completeness, accuracy, specification compliance, and emerging adverse trends. Prepares periodic environmental monitoring trend reports that summarize results, excursions, recurring observations, and recommended follow-up actions. Prepares the environmental monitoring content for monthly site management review slides, summarizing key metrics, trends, excursions, investigations, and risks. Supports the Quality Ops Team with review of executed batch records, batch disposition activities, quality on the floor, and completion of monthly quality walk throughs. Completes required training and maintains qualification for assigned duties.
Qualifications
BS 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, 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. Experience performing or reviewing environmental monitoring sampling and data is preferred.
Physical Requirements
Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Frequently lift and or move objects up to 30 pounds. Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus
FLSA: Non-Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.