US Operator

Alpharetta1w ago

About the role

Overview: We are seeking a meticulous and quality minded Operations Technician that works in a production Laboratory and/or Cleanroom setting to support the manufacturing of our bone graft product families. The technician 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. The payrate is $24.04 an hour. Key Responsibilities:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Support the commencement of our new manufacturing facility in Alpharetta, Georgia. This includes but not limited to: </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="2">Traveling to our Bilthoven, Netherlands manufacturing location for on-the-job training and knowledge transfer.  </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="2">Support the Execution of our IQ/OQ/PQ validation process prior to go-live of our new manufacturing </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="2">Support the development and continuous improvement of our training program.   </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Perform manual and semi-automated assembly of our Magnetos product family in an ISO Class 8 cleanroom and controlled lab environment. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Follow detailed work instructions, standard operating procedures (SOPs), and batch records accurately. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Operate and maintain cleanroom equipment and tools (e.g., graduated cylinders, vibration tables, scales, vacuum sealers, ovens, dispensers). </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Perform in-process inspections to verify quality specifications. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Handle sterile or non-sterile packaging and labeling of finished products, ensuring lot control and traceability. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Maintain cleanroom gowning protocols and adhere strictly to contamination control and hygiene standards. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Accurately complete production documentation, including batch records, in compliance with FDA 21 CFR Part 820 and ISO 13485. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Report deviations, non-conformances, or equipment malfunctions to quality personnel promptly. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">Support cleaning, calibration, and routine maintenance of equipment and cleanroom areas. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1">Collaborate with Quality, Process Development Engineering, R&D and Production teams on continuous improvement initiatives and process validations. </li> </ul> Qualifications:  <ul> <li>Education:   <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="2">Bachelor’s degree in Biology, Chemistry Engineering, Biology, or related field required.  </li> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="2">Lean Six Sigma Green Belt Certification preferred </li> </ul> </li> <li>Experience:   <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="2">0-2+ years in Operations within an ISO13485 regulated industry  </li> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="2">Experience working in an ISO 7 or ISO 8 cleanroom manufacturing process</li> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="2">Experience working with lean manufacturing principles and with in a 6S program.</li> </ul> </li> <li>Skills:  <ul> <li>Strong attention to detail and ability to follow precise work instructions.</li> <li>Excellent communication and interpersonal abilities</li> <li>Ability to stand for up to 8 hours/day</li> <li>Understanding in lean methodologies, Six Sigma tools and working within a 6S program.</li> <li>Proficiency within an ERP or MES systems, preferably in Microsoft Dynamics 365.</li> </ul> </li> </ul> Travel Requirement: <ul> <li>Ability to travel domestic and international</li> </ul>  <div class="content-pay-transparency"><div class="pay-input"><div class="title">Hourly Pay Rate</div><div class="pay-range">$19.23—$24.04 USD</div></div></div><div class="content-conclusion">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. <ul> <li>Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.</li> <li>Lifting/Carrying: May require lifting and carrying items 50 pounds or more, depending on the role.</li> <li>Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.</li> <li>Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license.</li> </ul> Specific requirements may vary by role. Contact an HR representative for details related to the position. <div class="description-container"> Our credentials </div> <div class="wysiwyg-content"> 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. <ul> <li>Listing on the SIX Swiss Exchange under the symbol KURN since 2016</li> <li>A commercial & research footprint that spans >20 markets</li> <li>Dozens of clinical and scientific expert Advisers</li> <li>>25 orthobiologics-related patents</li> <li>>400 patients evaluated in Level I, randomized controlled clinical trials</li> <li>>20 well-controlled Level I-IV clinical trials initiated, including 6 that are complete1</li> <li>Published Level I evidence published in Spine</li> </ul> </div> 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 <a href="https://kurosbio.com/privacy-policy/">here.</a>  </div>

747,000+ hidden jobs like this

Kuros Biosciences, Inc. and thousands of companies post here first — often days before LinkedIn or Indeed. Your first 5 applications are free; go Pro to apply without limits.

Everything Pro unlocks:

Unlimited applications — free stops at 5
Track every application in one place
Apply straight to the source, one click
Save & organize roles you love
Roles pulled from company boards before the big sites

Weekly

$9.99

$4.99/week

For an active search. Cancel anytime.

Get Weekly

Monthly

$24.99

$12.99/month

The smart pick. Save 35% vs weekly.

Get Monthly

Lifetime

$99

$49.99once

Pay once. Every future feature, forever.

Get Lifetime