Operator
Alpharetta, GA On-site
$50,003 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
We are seeking a meticulous and quality minded Operator that works in a production Laboratory and/or Cleanroom setting to support the manufacturing of our bone graft product families. The Operator will perform assembly, inspection, packaging, and documentation tasks in accordance with GMP, ISO 13485, and FDA regulations. This role is critical to ensuring product quality, traceability, and compliance throughout the production process. In the beginning, this role will support the validation and commencement of our new manufacturing facility in Alpharetta, Georgia. This is a full-time, hourly, on-site position based out of Alpharetta, GA. We are seeking a meticulous and quality minded Operator that works in a production Laboratory and/or Cleanroom setting to support the manufacturing of our bone graft product families. The Operator will perform assembly, inspection, packaging, and documentation tasks in accordance with GMP, ISO 13485, and FDA regulations. This role is critical to ensuring product quality, traceability, and compliance throughout the production process. This is a full-time, hourly, on-site position based out of Alpharetta, GA.
What you'll bring
- Bachelor’s degree in Biology, Chemistry Engineering, Biology, or related field required.
- 0-2+ years in Operations within an ISO13485 regulated industry
- Experience working in an ISO 7 or ISO 8 cleanroom manufacturing process
- Experience working with lean manufacturing principles and with in a 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
- Understanding in lean methodologies, Six Sigma tools and working within a 6S program.
- Proficiency within an ERP or MES systems
- Ability to travel domestic and international
- Cleanroom Requirements: Must be able to work in an ISO Class 8 cleanroom environment and comply with all applicable GMP, cleanroom, and contamination-control requirements, including restrictions on jewelry, cosmetics, and fragrances
- appropriate attire that provides adequate skin coverage