Position Overview: We are looking for a Clean Room Production Specialist to join our team. This pivotal role focuses on the meticulous operation of equipment within clean room environments, ensuring adherence to industry standards and regulations. The ideal candidate will have a keen eye for detail, strong technical skills, and a commitment to maintaining a sterile production atmosphere. SHIFT:
- Monday through Friday: 3rd shift (11pm-7:30am)
Pay:
Primary Responsibilities:
- Equipment Management: Operate and monitor production machinery, including filling and sealing systems, ensuring that all processes align with batch records and comply with 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.
Required Qualifications:
- 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.
Interested? Reach out to us for more details on the next steps in the application process. We look forward to hearing from you! #MedixNE