Roles & Responsibilities :
Perform Environmental Monitoring (EM) activities, including viable and non-viable air-borne sampling.
Conduct Plate Counts,Gram Staining, Water Sampling, Water Testing, and Micro / Macro analyses.
Operate handheld instruments such as Climate and SMA tools for environmental assessments.
Execute sampling and testing of Water for Injection (WFI),Water Purification Units (WPU),process gases, microbial testing, TOC (Total Organic Carbon), and other wet chemical tests.
Maintain expertise in aseptic techniques within a fast-paced GMP environment.
Ensure laboratory testing is completed in line with departmental policies and procedures.
Manage day-to-day Quality Control Lab operations, including testing, documentation, and maintenance of laboratory equipment.
Utilize trending software to analyze environmental data and ensure compliance with established standards.
Monitor performance metrics and implement CAPA (Corrective and Preventive Actions) when necessary to meet lab performance goals.
Provide technical support to the manufacturing team for issues identified during environmental monitoring and lab testing.
Participate in root cause investigations and support Process and Equipment Validation projects that require laboratory services.
Education & Experience :
Bachelor's Degree (B.S.)in a scientific discipline or equivalent combination of education and experience.
2-5 years of experience in environmental monitoring or a related field, preferably in a GMP environment.
Strong experience in cleaning validations and Environmental Monitoring Program Qualifications (EMPQ).
Proficiency in microbiological testing, aseptic techniques, and environmental monitoring equipment.
Familiarity with trending software for data analysis and reporting.
Ability to work effectively in a fast-paced, highly regulated environment.
Strong problem-solving skills and attention to detail.
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