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Research Associate

Employer
Scientific Search
Location
Groton, CT
Closing date
Oct 24, 2021

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Research Associate

Scientific Search client, a biotechnology start-up company that delivers diagnostic insights for safer pregnancies and healthier mothers and babies, has an immediate need for 2-3 temporary Research Associates. The Research Associate will participate in critical pre-launch R&D work including organizing logistics and materials for externally conducted studies, executing study protocols, participating in human factors studies, and analyzing laboratory data. The Research Associate is expected to comply with all quality procedures established within the Company and with Good Manufacturing Practices (GMP)/ Good Laboratory Practices (GLP).

This is a contract position of 4-6 months, with the potential to develop into a longer-term position. It is an exciting opportunity for a laboratory technologist or scientist who wants to be a key contributor to a team that is bringing important disruptive healthcare solutions to market.

Essential Responsibilities/Functions:

Key participant in studies designed to optimize end users' experience with clinical laboratory device(s). Provide thoughtful feedback on device instructions for use and training materials.
Perform laboratory experiments under protocol.
Analyze human specimens (urine) using various laboratory assays.
Follow written protocols and procedures, and document laboratory testing activities and results to ensure adherence to all applicable requirements of FDA, Quality Systems Regulations (QSR), and International Organization for Standardization (ISO).
Prepare laboratory solutions and materials for experimentation.
Control and fill lab record sheets in compliance with the Standard Quality/ISO requirements
Ensure compliance with the requirements of working in a regulated environment, assuring adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

Education and Experience:

Candidates for this position may be either scientists or laboratory technologists but must have experience working in an GMP or GLP environment, or healthcare facility laboratory performing sample and/or clinical laboratory testing.

Bachelor's degree in a chemical, physical, biological, or clinical laboratory science, or medical technology preferred with:At least 1 year of experience as a laboratory technologist in a health care facility clinical laboratory or reference lab licensed to perform Clinical Laboratory Improvement Act (CLIA) moderate testing.
Or, at least 1 year of experience as a research associate in a GMP or GLP laboratory.
Or, at least 1 year experience performing testing in a quality control laboratory
Or, an Associate's degree in laboratory science or medical technology with 3+ years of laboratory work experience.

Previous laboratory experience with lateral flow IVDs (In Vitro Diagnostics) a plus.

Skills and Abilities:

Experience in performing laboratory testing such as real time stability studies and interference studies or experience running diagnostic tests in a clinical laboratory licensed to perform CLIA moderate testing.
Knowledge and understanding of basic laboratory techniques including: 1) solution preparation, 2) use of standard laboratory equipment such as balances, micropipettes, pH meters, spectrophotometers, 3) proper human specimen handling, preparation, and storage, 4) knowledge of reagent handling and storage 5) awareness of factors that influence test results.
Ability to perform laboratory testing under the direction of a supervisory scientist
Knowledge of GMP (Good Manufacturing Practices) or GLP (Good Laboratory Practices) and Regulatory requirements
Seasoned experience using Microsoft Office (MS Word, Excel, and PowerPoint)
Precision, accuracy, and strong attention to detail
Excellent communication skills

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