R and D Spec - Stability Hybrid Schedule Mundelein
Company: Medline Industries, Inc.
Posted on: June 22, 2022
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).
- 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
- Compile risk assessments, identify gaps, and propose
- 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
- 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
- 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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