QA Associate - Environmental Monitoring

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.