GMP Manufacturing Technician
4 weeks ago
This is a full-time GMP Manufacturing Technician position located in a Current Good Manufacturing Practice (cGMP) environment. The successful candidate will be responsible for dispensing, manufacturing, and packaging operations while wearing appropriate PPE, maintaining accurate batch records, and following all Standard Operating Procedures (SOPs).
Key Responsibilities:
• Assist with dispensing, manufacturing, and packaging of GMP materials while wearing appropriate PPE, as required.
• Complete manufacturing batch records in accordance with GMP documentation requirements.
• Perform assigned tasks in a clean room, including cleaning equipment, instrumentation, and manufacturing suites.
• Maintain accurate records to support data integrity.
• Adhere to all SOPs, cGMP's, and applicable FDA regulations.
Requirements:
• High School Diploma/GED required, some college or technical training preferred.
• One (1) year of manufacturing operations or technical experience preferred; OR an equivalent combination of education, training, and experience.
• Prior knowledge preferred, or ability to be trained, in the use of drug product manufacturing equipment and instrumentation.
• Fundamental knowledge of practices and techniques to troubleshoot and solve problems.
• Conscientious, follows directions, willing to learn.
• Fundamental understanding of working with batch records and documenting in laboratory notebooks preferred.
• Effective methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.
Working Environment:
The work is performed in a lab and office setting. The work is subject to chemicals, fumes, gases, noxious odors, and related items in a lab setting.
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