Quality Control Lab Associate Specialist
Full Job Posting
Responsibilities
- Conduct routine environmental monitoring (EM) sampling, including active air, surface, and water systems testing across manufacturing areas.
- Perform in-process and finished product release testing, including sterility testing, residual moisture detection, and average cell dry weight testing.
- Apply aseptic techniques strictly while handling biological samples, evaluating microbiological cultures, and executing assays.
- Adhere strictly to Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMPs) across all lab activities and documentation.
- Collaborate with colleagues to identify and resolve technical or operational shop-floor issues guided by established policies and procedures.
- Evaluate experimental and environmental data, assist with report writing, troubleshoot assays, and participate in process improvement projects.
- Interact cross-functionally with Quality Assurance, Validation, Facilities, and Production teams to support seamless lab and plant operations.
- Maintain clear communication, ask clarifying questions, and ensure alignment with department objectives and next-level management.
Education
Bachelor's degree in Biology, Microbiology, Biochemistry, or a related scientific field; OR
Associate's degree in Biology, Microbiology, Biochemistry, or a related field plus 1–2 years of relevant laboratory or pharmaceutical industry experience.
Experience
Demonstrated understanding and practical application of GLPs, cGMPs, and aseptic technique.
Hands-on experience performing environmental monitoring and water systems sampling in a regulated environment.
Proven ability to work effectively within a collaborative, cross-functional team setting.
Preferred experience utilizing laboratory and production software systems such as LIMS or SAP.
Preferred strong written and verbal communication skills for data reporting and interdepartmental collaboration.
Additional Information
Shift Details: 1st Shift Days (Tuesday – Saturday); weekends required.
Working Hours: 8:30 AM – 5:00 PM (8-hour shift with a 30-minute lunch break), with flexibility for earlier or later start times based on Environmental Monitoring needs.
Role Impact: Shop-floor decision-making accountability guided by established SOPs and regulatory standards.
About Merck & Co., Inc.
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