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. Through this platform, we strive to improve outcomes for neurodegenerative, genetic, and rare diseases. If you are energetic, highly motivated, and want to work in a fast-paced, team-focused environment, then Aruna Bio wants to hear from you. The company is currently seeking to fill the following position:
• Maintain Quality Assurance documentation and detailed records that are legible, accurate and readily understood
• Review and dispositions executed batch records and supporting GMP/GLP documentation for completeness, accuracy and compliance with company procedures.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices
• Act as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by Management
• Act as first responder for quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions
• Write, revise and approve GMP documentation to support quality systems within the organization
• Participate in continuous improvement of core GxP process improvement initiatives
• Performs QA on the Floor activities supporting client projects, including, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing
• Works cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner
• Performs various routine analyses to collect, analyze and track environmental monitoring results and ensure compliance with established standards.
• Ensure that lab upkeep and safety standards are maintained.
• Ability to perform aseptic technique and use a variety of equipment such as biological safety cabinets, incubators, autoclaves, and particle analyzers.
• Safe handling, storage, and maintenance of chemicals according to Environmental Safety Division and OSHA regulations
• 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 Assurance Associate III
The QA Associate III is responsible for providing quality support and oversight to GMP and/or GLP activities. Daily activities will focus on but not be limited to routine quality assurance activities associated with manufacturing and testing, quality system maintenance and improvement initiatives, all aspects of environmental monitoring and compliance to GMP/GLP quality and regulatory standards.
Qualifications and Education
• Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs • Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks • Exposure to Lean Operational Excellence highly desirable • Self-starter with analytical skills and critical/logical thinking • Ability to work in laboratory setting with knowledge of basic chemical and biological safety procedures. • Ability to perform various environmental monitoring/microbiology tests, is preferred. • Excellent written and oral communication skills • Excellent organizational and documentation skills, with strict attention to detail • Ability to follow detailed written procedures with limited supervision • Good computer skills, including Microsoft word, Excel and PowerPoint. • Ability to handle multiple tasks concurrently and in a timely fashion • Demonstrated ability to work productively in a team environment is necessary Education and Experience: Minimum of a B.S. in a Life Sciences discipline with +5 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry and +2 years' experience in Quality Assurance/Quality Control function.
Qualified candidates submit a cover letter and resume to: firstname.lastname@example.org Subject line: QA Associate III