Quality-EM Associate I

Aruna Bio is advancing a new class of cell-free biologics, exosomes, for the treatment of central nervous system (CNS) and neurodegenerative disorders and leveraging our novel platform to optimize the delivery of RNAs, antibodies, genes, and small molecules for our partners. Through this platform and our partners, we strive to improve outcomes for CNS neurodegenerative, genetic, and rare diseases. Aruna Bio currently offers a wide range of full-time employee benefits that include: • Medical/Dental/Vision insurance options • Generous Paid Time Off • Generous Holiday calendar • Employee retirement plan • Employee training and professional development opportunities

Responsibilities

• Ensure that lab upkeep and safety standards are maintained. • Ability to use a variety of equipment such as pipettors, balances, laminar flow hoods, incubators, autoclaves, microscopes, centrifuges, plate readers, and particle analyzer. • Ability to perform aseptic technique and mammalian cell culture. • Maintain detailed records that are legible, accurate and readily understood. • Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms. • Performs various routine analyses to collect, analyze and track environmental monitoring results and ensure compliance with established standards. • Compile laboratory test data and perform appropriate analyses. • Report questionable test results and participate in OOS and failure investigations. • Assist in the development of test methods. • Participate as an analyst in qualification/validation for various microbiology methods according to applicable policies and guidelines. • Assist with troubleshooting of software or equipment malfunction to determine the source of error. • Follow company, GxP, and regulatory requirements, as applicable. • Supply QC data necessary for regulatory submissions. • Perform occasional work outside of the normal business hours, including weekend work. • Perform other appropriate duties as assigned by Supervisor or Management.

Position Description: Quality-EM Associate I

The Quality Assurance Associate II is responsible for supporting GMP and GLP activities, reporting to a QA supervisor or manager, with work occasionally directed. The QA associate II will gain exposure to some of the complex tasks within the job function. Activities include routine quality assurance activities associated with manufacturing andtesting, quality system maintenance and improvement initiatives, and complianceto GMP quality and regulatory standards.

Qualifications

•Ability to work in laboratory setting with knowledge of basic chemical and biological safety procedures. •Ability to perform various environmental monitoring/microbiology tests. •Excellent written and oral communication skills. •Exceptional organizational and documentation skills, with strict attention to detail. • Ability to follow detailed procedures with limited supervision. •Good computer skills, including Microsoft word, excel and powerpoint. •Ability to handle multiple tasks concurrently and in a timely fashion. • Ability to work collaboratively in a team environment. Education and Experience: Typically requires a bachelor’s degree in a biomedical science with 0 - 2 years microbiology related experience. Preference will be given to candidates with environmental monitoring experience in a cGMP environment.
Qualified candidates submit a cover letter and resume to: jobs@arunabio.com Subject line: Quality/EM Associate 1