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R and D Spec - Stability Hybrid Schedule Mundelein

Company: Medline Industries, Inc.
Location: Mundelein
Posted on: June 22, 2022

Job Description:

JOB SUMMARY Responsible for contributing to the development of new products and technologies within the R&D group through stability and shelf life determination. The role will be a subject matter expert in a product stability and will facilitate project needs related to that knowledge. Areas of focus may include performance testing, stability indicating test identification, stability generation and processing, acceptance criteria determination, risk assessments, etc. This position follows a hybrid schedule model of work (Tues/Thurs in office). RESPONSIBILITIES INCLUDE:

  • Author and review stability test protocols and reports.
  • Plan and execute or otherwise help to facilitate required stability indicating tests in support of product studies.
  • Track, compile, analyze, and review all stability test results against stability indicating test acceptance criteria in support of product requirements and regulatory submissions such as 510k%26rsquo;s, CE technical files, and ANDA/NDAs.
  • Compile technical justifications and data summaries in support of product shelf life and research studies.
  • Identify and support the development of product requirements, performance attributes, and quality specifications.
  • Ensure compliance of all data collection activities with applicable regulatory requirements.
  • Participate in the support of internal and external audits.
  • Compile risk assessments, identify gaps, and propose solutions.
  • Lead process improvement, CAPA, OOS investigations, and data trending activities as it relates to stability processes
  • Interpretation of stability related standards and generation of GAP analysis when compared to our existing procedures COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.
    • Bachelor of Science in Chemistry, Biology or related field.
    • A least 2 years of experience in a medical device or pharmaceutical related field. Stability related preferred.
    • Knowledge of FDA requirements and experience with FDA interactions as part of the 510k/ANDA/NDA approval processes.
    • Knowledge of CE technical files.
    • Experience with risk assessment and root cause analysis.
    • Experience solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists for stability related processes.
    • Experience communicating with internal and external business partners and cross functional teams with various audiences.
    • Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills.
    • Position may require travel up to 10% of the time for business purposes (domestic and international).

Keywords: Medline Industries, Inc., Arlington Heights , R and D Spec - Stability Hybrid Schedule Mundelein, Other , Mundelein, Illinois

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