Senior Specialist QA - I
Key Skills for This Role
Full Job Posting
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.
About Merck & Co., Inc.
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