10 дней назад
Histology Applications Scientist
40 - 50$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Histology Applications Scientist (Histology/Validation): Supporting histology product validation and Design History File remediation for a medical device manufacturing organization with an accent on representative histology workflows, protocol execution, and controlled documentation. Focus on developing acceptance criteria, evaluating tissue-processing and staining performance, distinguishing product findings from laboratory variables, and producing traceable validation reports.
Location: Richmond, Illinois; on-site only. Monday–Friday, 40 hours per week, day shift. Relocation assistance is not available.
Pay rate: $40–$50 per hour. Duration: 14-month contract through the end of 2027. Start date: October 2026.
Company
provides specialized consulting and workforce solutions for life sciences organizations across Quality, Regulatory, Clinical, Engineering, and Scientific functions.
What you will do
- Develop user-validation and applications-testing protocols covering product requirements, intended use, user needs, workflows, acceptance criteria, and objective evidence.
- Execute simulated-use and representative-use testing with standard histology workflows.
- Prepare, process, embed, section, stain, coverslip, and evaluate tissue specimens.
- Perform tissue processing, paraffin embedding, microtomy, H&E staining, reagent handling, and slide-quality assessment.
- Document deviations, usability issues, workflow limitations, and findings while separating product-related issues from technique, specimen, reagent, and equipment variation.
- Prepare validation reports and author or review Design History File documentation, including requirements, specifications, risk-management records, protocols, and reports.
Requirements
- Bachelor’s degree in Biology, Biomedical Science, Medical Laboratory Science, Histotechnology, Pathology, Anatomy, Physiology, Chemistry, or a related life-science discipline.
- HT(ASCP) certification or equivalent hands-on histology laboratory experience.
- At least 2 years of experience in a regulated industry working with design-control documentation.
- Experience developing and/or executing test protocols.
- Proficiency with Microsoft Office.
- Basic understanding of quality systems such as ISO 9001 and ISO 13485.
Nice to have
- Independent competency in embedding, microtomy, tissue processing, routine staining, coverslipping, slide-quality review, and troubleshooting histology artifacts.
- Experience with automated or manual tissue processors, microtomes, embedding centers, autostainers, and coverslipping equipment.
- Experience documenting laboratory activities through controlled records, protocols, validation reports, or quality-system documentation.
- Strong troubleshooting skills for histology workflows and laboratory-process variables.
Culture & Benefits
- On-site work in a medical device manufacturing environment.
- Day-shift schedule from Monday through Friday.
- 14-month contract assignment through the end of 2027.
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