Clean Room Production Specialist
6 hours ago
Job Summary:
We are seeking a highly skilled Clean Room Production Specialist to join our team at Medix™. This role involves operating and monitoring production machinery in clean room environments, ensuring adherence to industry standards and regulations.
Key Responsibilities:
- Equipment Management: Operate and monitor production machinery, including filling and sealing systems, to ensure compliance with batch records and established SOPs and cGMP standards.
- Preparation and Setup: Prepare clean room areas and necessary equipment for production runs, verifying that all materials and components meet quality and schedule requirements.
- Gowning Procedures: Follow strict gowning protocols and best practices for aseptic technique to minimize contamination risks while working in controlled environments.
- Cleanliness and Sanitation: Execute regular cleaning and sanitization tasks for production areas and equipment, ensuring compliance with environmental control standards and maintaining a contamination-free environment.
- Accurate Record-Keeping: Ensure thorough documentation of all operational activities, in line with Good Documentation Practices (GDP), to maintain transparency and traceability.
- Team Support and Development: Actively participate in training initiatives for new team members, sharing best practices to foster a culture of compliance and efficiency within the team.
- Quality Assurance: Collaborate with quality assurance teams to monitor processes and quickly address any deviations from standard operating procedures or safety protocols.
Requirements:
- High school diploma or equivalent; a degree in a related field is a plus.
- At least 2 years of experience in a clean room setting, preferably in the pharmaceutical or biotechnology sector.
- Demonstrated knowledge of gowning procedures and clean room operational protocols.
- Understanding of GMP, FDA regulations, and relevant industry standards.
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