Manufacturing Operations Senior Associate

Role Summary

The Manufacturing Operations Senior Associate is responsible for daily GMP manufacturing operations in the DPF, including the assembly, set-up, operation, disassembly, and cleaning of process equipment.

Responsibilities

• Understanding of and strict adherence to cGMP requirements
• Compliance with all on-going training requirements
• Following Batch Records, SOPs, policies and all other relevant work instructions to ensure the successful and compliant operation of the drug product facility
• Interfacing with cleaning staff, Facilities/Operations, Quality, EH&S, Materials Management and the Release and Stability Laboratory to ensure facility operation
• Entering of data into log books and batch records
• Interfacing with computerized systems and automated process equipment

Skills

• Ability to follow verbal and written instructions in English
• Visual Acuity
• Ability to distinguish between the colors red, yellow, blue and green
• Ability to lift up to 50lbs
• Solid communication and documentation skills
• Organizational skills
• Basic computer skills and demonstrated ability to learn new systems and understand new technologies
• Ability to perform shift work as required.

Education

• High School degree
• High School degree and 3 years of experience, or the equivalent combination of education and experience in a related field