Medical Laboratory Technician
2 weeks ago
We are seeking an Environmental Monitoring Technician to support the monitoring and testing operations for an ISO-standard classified manufacturing plant. The ideal candidate will have hands-on experience in environmental monitoring, water sampling/testing, and operating within a GMP environment using aseptic techniques. This role involves working closely with the manufacturing team, quality control laboratory, and supporting various process validation efforts.
Key Responsibilities:
- Perform environmental monitoring (viable and non-viable air-borne monitoring) and related testing.
- Collect and test samples of Water for Pharmaceutical Use (WPU), Water for Injection (WFI), and process gases.
- Conduct microbial testing, Total Organic Carbon (TOC) analysis, and other wet chemical testing.
- Utilize handheld instruments such as Climate and SMA for sampling and monitoring.
- Execute plate counts, gram staining, water sampling/testing, and micro/macro testing.
- Ensure the setup, organization, and day-to-day operations of the Quality Control Lab.
- Monitor the lab's performance against targets and address deviations through CAPA.
- Maintain accurate documentation of testing activities and laboratory maintenance.
- Ensure compliance with GMP and ISO standards, supporting awareness of regulatory requirements.
- Provide technical support to manufacturing operations, including troubleshooting and root cause investigations.
- Assist in Process and Equipment Validation projects involving laboratory services.
Qualifications:
- Bachelor’s Degree (B.S.) in a related field or an equivalent combination of education and experience.
- 2-5 years of relevant experience, with a preference for experience in cleaning validation and Environmental Monitoring Performance Qualification (EMPQ).
- Familiarity with GMP practices and aseptic techniques in a fast-paced environment.
- Experience with trending software to track and report monitoring data.
- Knowledge of departmental policies and procedures in a Quality Control lab environment.
Skills & Attributes:
- Strong attention to detail and the ability to manage multiple tasks efficiently.
- Proficiency in laboratory testing, documentation, and troubleshooting.
- Ability to work collaboratively within a team and provide technical support to manufacturing.
- Experience in performance monitoring, data analysis, and CAPA implementation.
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