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Hybrid Document Control Specialist I chez Stimlabs

Stimlabs · Roswell, États-Unis d'Amérique · Hybrid

39 000,00 $US  -  46 800,00 $US

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

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KEY DUTIES AND RESPONSIBILITIES


Provides key Quality support to the StimLabs organization
  • Acts as a quality representative within the organization, raising awareness for quality.
  • Contributes to the organization of quality documents.
  • Assists on a variety of projects and participates in daily Quality activities.
  • Suggests and assists with continuous improvement projects within the Quality System. 


    • Participates in daily operations of the Quality department including but not limited to:
  • Assists with records management and the Document Control system.
  • Maintains and ensures all quality documents are scanned and saved on the server.
  • Files all paperwork in the correct locations.
  • Keeps lists updated for control of records/binders.
  • Assists in organizing, scanning, and saving Supplier files.
  • Support inspections and audits from regulatory agencies, as needed.
  • General administrative tasks such as scheduling, filing, organizing etc.
  • Batch Records: Files all necessary paperwork in batch records (Deviations, NCRs, CAPAs)
  • Donor Charts: Files copies of Distribution Logs into Donor Charts, Files all additional communications of updated donor eligibility into donor charts, Uploads and files donor chart documentation such as serology and culture results where applicable.
  • Proficient in using Windows and applicable applications.
  • Schedules meetings where appropriate.
  • Other Quality functions as designated and trained by Management (e.g., Releasing batch records, Tissue Utilization Records, Environmental Monitoring, Supplier File Maintenance, Quality Review of records etc.).


    • EDUCATION/CERTIFICATION
  • High school diploma with industry experience or appropriate combination of education and experience.
  • Experience in communication at all levels, meticulous, and self-motivated.
  • Requires basic Microsoft Windows experience (MS Word, Excel, PowerPoint, Outlook etc.).


    • REQUIRED KNOWLEDGE
  • Knowledge and understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations.
  • Document Control Management (document changes as well as maintenance of Quality records) in a cGMP regulated environment a plus. 


    • Job Details
  • Monday to Friday, 8a to 5p


    • StimLabs was founded in 2015 with a desire to advance the state of regenerative medicine. In pursuit of this goal, StimLabs has gathered exceptional scientific and clinical minds to develop and commercialize new bioactive technologies. While current technologies in medical devices, pharmaceuticals, and tissue banking provide useful products, StimLabs believes in the untapped synergy at the intersection of these independent domains. In the first steps towards this vision, StimLabs has launched a suite of next-generation amniotic-derived products. The success of these initial offerings has created a foundation on which StimLabs will continue building the future of regenerative medicine.
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