Cleanroom Operator — GMP/ISO 13485, Training & Validation

Kuros Biosciences, Inc.; Atlanta (GA); On-site; USD 40,000 - 50,000; Full time

Job summary

Kuros Biosciences, Inc. seeks a meticulous Operator to support manufacturing of bone graft product families in a production laboratory and/or cleanroom. You will perform assembly, inspection, packaging, and documentation in GMP/ISO 13485 environments and help validate a new Alpharetta facility.

The role is on-site in Alpharetta, GA, with travel for training and a Mon-Fri 7:30 AM–4 PM schedule. Requires a biology/chemistry/engineering background and strong attention to detail.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, Biology, or related field.
• Lean Six Sigma Green Belt Certification preferred.

Responsibilities

• Support the commencement of our new manufacturing facility in Alpharetta, GA.
• Perform manual and semi-automated assembly in an ISO Class 8 cleanroom.
• Follow SOPs and batch records to ensure traceability and quality.
• Operate and maintain cleanroom equipment and tools as required.
• Complete production documentation per FDA 21 CFR Part 820 and ISO 13485.
• Collaborate with Quality, Process Development Engineering, R&D and Production for improvements.

Skills

Attention to detail

Communication

Stand for 8 hours

Lean Six Sigma knowledge

ERP/MES: Microsoft Dynamics 365

Education

Bachelor’s degree in Biology, Chemistry, Engineering, or related field

Lean Six Sigma Green Belt Certification

Tools

Microsoft Dynamics 365

Job description

Kuros Biosciences, Inc. seeks a meticulous Operator to support manufacturing of bone graft product families in a production laboratory and/or cleanroom. You will perform assembly, inspection, packaging, and documentation in GMP/ISO 13485 environments and help validate a new Alpharetta facility.

The role is on-site in Alpharetta, GA, with travel for training and a Mon-Fri 7:30 AM–4 PM schedule. Requires a biology/chemistry/engineering background and strong attention to detail.