The Associate of Manufacturing will play a crucial role in supporting production operations in a dynamic environment at Rhode Island Drug Substance plant. This position involves hands-on operations, working within strict compliance to GMP guidelines, and contributing to the production of commercial, clinical, and launch products. The ideal candidate values safety, demonstrates teamwork, and thrives in a collaborative manufacturing or chemical processing setting.
Key Responsibilities:
- Perform hands-on tasks such as equipment setup, cleaning, and sanitization.
- Execute manufacturing processes, including buffer/media preparation and in-process sampling.
- Operate, monitor, and troubleshoot manufacturing equipment in compliance with GMP guidelines.
- Conduct routine testing, sterilization activities, and parts washing.
- Maintain an organized and clean workspace, ensuring adherence to safety protocols.
- Support document drafting, revision (SOPs, MPs), and quality deviation reporting.
- Participate in method improvement initiatives and drive lean transformation efforts.
- Collaborate with cross-functional teams to ensure seamless production processes.
- Uphold a strong safety culture, particularly in environments requiring cleanroom protocols.
- Support inspections, audits, and ongoing compliance with industry standards.
Physical and Behavioral Expectations:
- Ability to lift up to 35 lbs and work on your feet for extended periods.
- Comfortable working in cleanroom attire, including steel-toe shoes and full gowning.
- Exhibit critical thinking, focus, and adherence to written protocols.
- Display leadership qualities, fostering a collaborative and positive work environment.
- Adjust tasks based on shifting priorities and assess operational effectiveness.
Qualifications:
- Basic Qualifications:
- Bachelor’s degree OR
- High school diploma/GED with at least 3 years of manufacturing experience.
- Preferred Experience and Skills:
- Familiarity with lab environments and chemical handling.
- Strong teamwork and communication skills.
- General computer proficiency, particularly in MS Office Suite (O365).
- Experience troubleshooting processes or equipment.
- Shift:
- 6:45PM - 6:45AM Rotation
- Swing Shift
