Senior Specialist QA - I

Summary Join a globally trusted manufacturing network dedicated to delivering high-quality, reliable biopharmaceutical supplies to patients worldwide. As an Associate Specialist in Quality Control, you will join a Quality group that ensures every material inside our products meets stringent regulatory standards and quality requirements. Working in a collaborative team environment, you will assist in product quality assurance by conducting microbiological, chemical, and analytical sampling, while partnering closely with Production, Quality Assurance, Validation, and Facilities teams.

Responsibilities

• Conduct environmental monitoring sampling, including active air, surface, and water sampling across facilities.
• Perform release testing for finished products, including sterility testing, residual moisture detection, and average cell dry weight testing.
• Execute microbiological testing and evaluate environmental microbiological samples.
• Conduct in-process and routine environmental monitoring testing in support of manufacturing operations.
• Evaluate laboratory data, conduct troubleshooting, participate in process improvements, and contribute to report writing and interdepartmental committees.
• Identify and resolve technical or operational shop-floor problems under guidance from department heads while adhering to established policies and procedures.
• Interact cross-functionally with internal departments and external resources to maintain seamless manufacturing support.

Education

• Associate's or Bachelor's degree in Biology, Microbiology, Biochemistry, or a related scientific field.

Experience

• Associate's degree holders require 1–2 years of relevant laboratory or pharmaceutical experience (Bachelor's degree requires equivalent academic/foundational background).
• Demonstrated understanding and application of Good Laboratory Practices (GLP) and cGMPs.
• Hands-on proficiency in aseptic technique and performance of environmental and water systems monitoring.
• Strong written and verbal communication skills, with preferred experience using LIMS, SAP, or other laboratory/production software systems.

Additional Information

• Position Type & Quantity: 2 openings available.
• Shift Structure: 1st Shift Days (8:30 AM – 5:00 PM with flexibility for earlier or later start times based on environmental monitoring needs). Includes an 8-hour shift with a 30-minute lunch break.
• Weekend Work Required: Schedules available are Sunday – Thursday OR Tuesday – Saturday.