QC/Production Associate I
Not Disclosed•Full-TimeOn-site
location_on24043, Tryon Road, Oakwood, Cuyahoga County, Ohio, 44146, United States
About the Role
Join our team as a QC/Production Associate I, where you will play a key role in producing life-changing drug products. In this position, you will ensure the highest quality standards through hands-on work with advanced radiosynthesizers and analytical equipment. You will operate synthesis units and QC instruments to produce FDG and NaF, while maintaining a clean, safe, and compliant working environment within ISO classified areas.
Our Commitment to Quality and Safety
Safety and compliance are at the heart of our operations. As a member of the team, you will perform radiation safety duties in accordance with SOFIE's Corporate Radiation Compliance Program and site licensing requirements. You will also maintain all qualification and validation requirements for entering classified areas, ensuring that every step of the production and quality control process meets rigorous cGMP documentation standards.
Team Environment
You will work in a fast-paced, highly technical environment that values detail, accountability, and teamwork. Success in this role requires the ability to communicate professionally with colleagues and customers, troubleshoot equipment issues with local and Network support resources, and adapt to various shifts and weekends. We are looking for individuals who are patient, organized, and dependable as they contribute to the mission of delivering critical pharmaceutical products.
Work location
Work model: On-site
24043, Tryon Road, Oakwood, Cuyahoga County, Ohio, 44146, United States
Oakwood, Ohio
Key Responsibilities
- check_circleOperate radiosynthesizers to perform FDG and NaF synthesis according to SOPs
- check_circlePerform basic computer-controlled cyclotron operations under engineer advisement
Similar Job Opportunities
Skills, education and keywords
Skills: Radiosynthesizers, Analytical Equipment, FDG, Naf, Sofie, Sop, CGM P, MS Office Suite, Cyclotron, Iso.
Education: High school diploma required; Associates degree in chemistry, engineering, or natural sciences preferred.
Frequently asked questions about QC/Production Associate I at SOFIE
What does a QC/Production Associate I at SOFIE do?expand_more
A QC/Production Associate I at SOFIE is responsible for the following: Operate radiosynthesizers to perform FDG and NaF synthesis according to SOPs; Perform basic computer-controlled cyclotron operations under engineer advisement; Perform radiation safety duties and maintain ISO classified area qualifications; and Clean classified and non-classified areas and perform environmental monitoring.
What are the requirements for this QC/Production Associate I role?expand_more
To qualify for the QC/Production Associate I at SOFIE position, applicants should have: High school diploma required; Associates degree in chemistry, engineering, or natural sciences preferred; Technical experience with computer-controlled automation preferred; Efficient in the use of MS Office Suite required; Ability to work various shifts and weekends required; and Ability to lift ~50 lbs. required.
Where is the QC/Production Associate I role at SOFIE located?expand_more
QC/Production Associate I at SOFIE is based in 24043, Tryon Road, Oakwood, Cuyahoga County, Ohio, 44146, United States. This is a on-site role.