US Operator
$39,998–$50,003 year
On-site · Atlanta, Georgia, United States or Alpharetta, Georgia, United States
Job Summary
Meticulous Operations Technician in a production laboratory/cleanroom supporting bone graft manufacturing. Responsibilities include assembling, inspecting, packaging, and documenting per GMP, ISO 13485, and FDA requirements; participating in IQ/OQ/PQ validation for a new Alpharetta facility; traveling for on-the-job training to Bilthoven; contributing to training program development; maintaining cleanroom operations and batch records; ensuring lot control and traceability; complying with contamination controls and gowning; collaborating with Quality, Process Development Engineering, R&D, and Production on continuous improvement and process validations.
Required Qualifications
- Bachelor’s degree in Biology, Chemistry, Engineering, Biology, or related field required
- Lean Six Sigma Green Belt Certification preferred
- 0-2+ years in Operations within an ISO13485 regulated industry
- Experience in ISO 7 or ISO 8 cleanroom manufacturing
- Experience with lean manufacturing and 6S program
- Strong attention to detail and ability to follow precise work instructions
- Excellent communication and interpersonal abilities
- Ability to stand for up to 8 hours/day
- ERP or MES systems experience, preferably Microsoft Dynamics 365
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