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30 days old

Documentation Biocompatibility Analyst

Kelly Services
Blue Ash, OH 45242
**Biocompatibility Analyst**


**Blue Ash, OH**


**Pay $32 per hour**


**Long Term with full benefits**


**Responsibilities**


**Material Documentation Support and Testing**


+ Compile data from testing or other evaluation/approval documentation for JNJ 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 requests


**Data Searches**


+ Maintenance and data entry in Biocompatibility Vital Records and the Biocompatibility Database

+ Research material- and biocompatibility-related questions, including database searches


**Qualifications**


+ Bachelors degree in Biology or 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** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-08-23 Expires: 2021-10-23

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Documentation Biocompatibility Analyst

Kelly Services
Blue Ash, OH 45242

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