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Senior Operator
Senior OperatorKuros Biosciences, Inc. • Alpharetta, GA, US
Senior Operator

Senior Operator

Kuros Biosciences, Inc. • Alpharetta, GA, US
[job_card.variable_days_ago]
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  • [job_card.full_time]
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Job Description

Job Description

Overview :

We are seeking a meticulous and quality minded Senior Operator that works in a production Laboratory and / or Cleanroom setting to support the manufacturing of our bone graft product families. The role includes hands-on assembly, inspection and packaging of our finish products as well as mentoring junior technicians, supporting validations and ensuring strict adherence to GMP and ISO 13485 standards. In the beginning, the role will support the validation and commencement of our new manufacturing facility in Alpharetta, Georgia. This is a full-time, on-site position.

Key Responsibilities :

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

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).
  • Support training of newly onboarded operators.
  • 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 & Skills :

  • Education :

    • Bachelor's degree in biology, Chemistry Engineering, Biology, or related field required.

  • Lean Six Sigma Green Belt Certification is preferred
  • Experience :

    • 3+ 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 within 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 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 :

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

    • Pay Range

    $55,000—$65,000 USD

    Physical Requirements and Work Conditions

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

  • Mobility & Posture : May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
  • Lifting / Carrying : May require lifting and carrying items 50 pounds or more, depending on the role.
  • Manual Dexterity : Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
  • Driving : Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver's license.

    • Specific requirements may vary by role. Contact an HR representative for details related to the position.

    Our credentials

    Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016 (under symbol KURN). With additional operations in the Netherlands and the USA, we continue to grow our global team.

    To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to advance bone healing.

  • Listing on the SIX Swiss Exchange under the symbol KURN since 2016
  • A commercial & research footprint that spans >

    • 20 markets

  • Dozens of clinical and scientific expert Advisers

    • 25 orthobiologics-related patents

    400 patients evaluated in Level I, randomized controlled clinical trials

    20 well-controlled Level I-IV clinical trials initiated , including 6 that are complete1

  • Published Level I evidence published in Spine

    • Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.

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    Senior Operator • Alpharetta, GA, US

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