Quality Assurance Associate II

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

• Audit GMP/GLP processes to ensure internal and external regulations and standards are followed and ensures auditing documentation is kept up to date. • Assist with revision of quality system and company procedures to comply with GxP and regulatory requirements • Train and provide assistance to organizational team members on quality procedures, protocols, and documentation • Maintain Quality Assurance documentation and detailed records that are legible, accurate and readily understood • Administering document control and change control system • Responsible for writing Standard Operating Procedures (SOPs) needed to support quality systems • Review of GMP/GLP documents to ensure compliance with company procedures and compliance with quality standards • Drive continuous improvement of core GMP/GLP processes • Compile key performance indicators and standard quality measurements • Coordinate investigation of quality issues with customers and suppliers • Investigate measurements that are found to deviate from standards, and tracking and trending root causes and CAPAs • Perform occasional work outside of the normal business hours, including weekend work • Take initiative as problems and/or opportunities arise • Perform other appropriate duties as assigned by Supervisor or Management.

Position Description: Quality Assurance Associate II

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

•Self starter with analytical skills and critical/logical thinking •Excellent written and oral communication skills •Excellent organizational and documentation skills, with strict attention to detail •Ability to write and follow detailed written procedures with limited oversight •Excellent computer skills, including Microsoft word, excel and powerpoint. •Proven ability to manage multiple projects while meeting high priority deadlines with limited oversight. •Demonstrated productivity and professionalism while working in a team environment. •Ability to work independently with integrity and with limited supervision Education and Experience: Typically requires a bachelor’s degree in a biomedical science with a minimum of 4 years related experience in a quality assurance role. ASQ certification preferred. Preference will be given to candidates with GMP experience in a cell based or biological therapeutics manufacturing setting.
Qualified candidates submit a cover letter and resume to: jobs@arunabio.com Subject line: QA Associate 2