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Documentation Biocompatibility Analyst

Company: Kelly Services
Location: Hamilton
Posted on: April 9, 2021

Job Description:

Documentation Biocompatibility Analyst Blue Ash, OH--Pay $32 per hourLong Term with full benefitsResponsibilitiesMaterial Documentation Support and Testing

  • Compile data from testing or other evaluation/approval documentation for databases and archives
  • Set up document templates, and review and fill out portions of the Biocompatibility Evaluation form (data tables, names, results, parameters, etc.)
  • Review memos for biocompatibility strategies, material approvals, and device approvals
  • Review device Bill of Materials, engineering drawings, and supplier documentation for accuracy and transcription to new documents, for material and manufacturing process information, and for identification of potential biocompatibility impact
  • Assist engineers in the preparation of biocompatibility samples to be sent for testing by providing guidance on sample collection, handling, packaging, and inspection
  • Coordinate testing of biocompatibility samples with contract laboratories, determine sample requirements, and review and provide feedback on engineering studies
  • Verify accuracy of test-sample information on analytical test reports and the presentation of the data.-- Verify risk assessment calculations (basic algebra) for Toxicologists
  • Create and manage documentation for Vital Records
  • Maintain and track biocompatibility test samples through progression of testing and to final off-site storage
  • Retrieve records in support of audits and regulatory requestsData Searches
    • Maintenance and data entry in Biocompatibility Vital Records and the Biocompatibility Database
    • Research material- and biocompatibility-related questions, including database searchesQualifications
      • The ideal candidate should have a background in documentation--
      • Bachelor's degree in Biology or Material Science is preferred
      • Experience with medical device/pharmaceutical industry is preferred
      • Familiarity with ISO 10993, FDA 21 CFR Part 820, and ISO 13485 is preferred
      • Must possess solid communication skills as they will be interacting with internal and external customers
      • Must possess solid collaboration skills and be able to work in a team environment
      • Work independently with little to no supervision and have initiative to drive projects forward--
      • Able to work on a variety of projects and shift priorities as needed
      • Able to prioritize, organize, and plan with adherence to deadlines, and communicate any deadline obstacles in a timely manner
      • Attention to detail and organization of data with high degree of confidentiality
      • Able to follow procedures with accuracy and precision, including a sequence of tasks
      • Able to ask questions, present different options in group consultation, and accept reinstruction on tasks
      • Computer skills required - Windows, MS Office (with an emphasis on Excel and Word)Why Kelly--? The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG--) is one focus within the full array of Kelly Services workforce solutions. Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs. About Kelly Services-- As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter. Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Hamilton , Documentation Biocompatibility Analyst, Professions , Hamilton, Ohio

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