Operator

Overview:

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. 

Schedule: Monday-Friday from 7:30 AM to 4 PM. 

Pay Rate: $24.04 an hour

Key Responsibilities: 

• Support the commencement of our new manufacturing facility in Alpharetta, Georgia. This includes but not limited to: 

• Traveling to our Bilthoven, Netherlands manufacturing location for on-the-job training and knowledge transfer.  

• Support the Execution of our IQ/OQ/PQ validation process prior to go-live of our new manufacturing 

• Support the development and continuous improvement of our training program.   

• Perform manual and semi-automated assembly of our Magnetos product family in an ISO Class 8 cleanroom and controlled lab environment. 

• Follow detailed work instructions, standard operating procedures (SOPs), and batch records accurately. 

• Operate and maintain cleanroom equipment and tools (e.g., graduated cylinders, vibration tables, scales, vacuum sealers, ovens, dispensers). 

• Perform in-process inspections to verify quality specifications. 

• Handle sterile or non-sterile packaging and labeling of finished products, ensuring lot control and traceability. 

• Maintain cleanroom gowning protocols and adhere strictly to contamination control and hygiene standards. 

• Accurately complete production documentation, including batch records, in compliance with FDA 21 CFR Part 820 and ISO 13485. 

• Report deviations, non-conformances, or equipment malfunctions to quality personnel promptly. 

• Support cleaning, calibration, and routine maintenance of equipment and cleanroom areas. 

• Collaborate with Quality, Process Development Engineering, R&D and Production teams on continuous improvement initiatives and process validations. 

Qualifications: 

• Education:  
  • Bachelor’s degree in Biology, Chemistry Engineering, Biology, or related field required.  
  • Lean Six Sigma Green Belt Certification preferred 
• Experience:  
  • 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.
• Skills: 
  • 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, preferably in Microsoft Dynamics 365.

Travel Requirement:

• 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; and gowning requirements, including the use of gowns, gloves, hairnets, beard covers (as applicable), and shoe covers. Employees must maintain personal grooming standards that support cleanroom operations, safety, and product quality, including natural, unpolished fingernails and proper hair restraint for long hair.