iCubate Quality Systems Associate – HudsonAlpha Institute for Biotechnology – Huntsville, AL, USA
iCubate ® (icubate.com), is a privately-held molecular diagnostic company based within the HudsonAlpha Institute for Biotechnology in Huntsville, Alabama.iCubate ® has a novel mPCR technology and integrated platform for automated sample preparation, multiplex amplification and detection for infectious disease diagnostics and research applications.
iCubate – Quality Systems Associate
iCubate® is seeking a Quality Systems Associate to work within the Quality Systems group to develop, implement and maintain a quality system in accordance with FDA Quality System Regulations, GMP guidelines and ISO 13485 requirements. As a member of the Quality Systems group, the successful candidate will assist with guiding multiple products through a FDA 510(k) process.
Position Summary
- Work within the company’s Quality Control team and provide leadership in certain areas
- Perform a central part in maintaining a controlled environment through an environmental monitoring plan, personnel controls and exceptional laboratory material
- Perform a central part in developing and maintaining a broad set of FDA Quality Compliance, Release and Systems activities for the successful production and release of in-vitro diagnostic products
- Create and implement Non Conformance Reports and Corrective and Preventative Actions (CAPA)
- Work with Regulatory Consultants to prepare 510K submission
- Work to develop and implement the company’s Quality System including the development of new SOP’s, FORMs, Test Procedures and Work Procedures
- Provide a strong understanding of Supplier Quality, Cold Chain Management, Logistics and Distribution, Design Control, Risk Analysis, and Statistical Process Control
Critical Competencies
- Ability to organize and maintain quality and regulatory documentation
- Ability to collaborate across the company (internal and consultants) at all levels, across functional groups
- Ability to foster excellent relationships and credibility quickly at all levels of the organization.
- Ability to demonstrate a positive, results-oriented style
- Abilityto present complex information to internal and external audiences
- Ability to express abstract and controversial ideas clearly and effectively
- Ability to use an analytical approach and evaluate a situation from varying perspectives to create well-reasoned solutions
- Ability to provide a good balance of risk taking and sound judgment in order to deliver optimal results
Education and Required Skills Experience
Education/Experience:
- Bachelors of Science in biochemistry, molecular biology, microbiology, chemistry or genetics
- 2+ years working in FDA-regulated Quality Environment
- 2+ years working with a quality systems team in a clinical environment
- Working knowledge of ISO 13485 and FDA 21 CFR 820 Quality System Regulation
- Experience in molecular biology or molecular diagnostics preferred
- 2+ years medical device product development preferred
- QC method design, optimization and validation experience required
- 2+ years writing protocols, SOPs, etc.
Benefits:
iCubate ® offers excellent employee benefits including an employer matching retirement plan and insurance package (including medical, vision, and dental). Additionally, iCubate ® offers company paid short and long-term disability and life insurance.
