Duties and Responsibilities
- Collaborate on Quality processes, procedures, work instructions, and forms, in particular, administer the Document Control and Change Order Processes.
- Work cross-functionally as part of a project team to aid departments in process improvement and procedure writing.
- Assist in the creation of QA deliverables for the New Product Development and Introduction process.
- Revise training requirements (and work with HR on implementing said requirements) for Quality Management System activities, including SOPs
- Generate metrics for critical-to-quality process
- Participate in internal and external audits as required
- Assist and collaborate with other department such as Manufacturing, Quality Control, Clinical Affairs, and Regulatory to ensure continued compliance, product quality, and safety
- Address issues related to quality concerns, implementing effective solutions and corrective actions
- Review and approve internal CAPAs, Deviations, NCMRs and other quality processes as needed.
- Assist in Product Complaint investigations, Material, Change Review Boards as needed.
- Other duties, as required
Qualifications
- Bachelor’s degree or higher in Science or Engineering field
- 1 to 3 years QA experience in an ISO 13485 Certified or FDA regulated company
- Technical/Procedure writing, and process mapping experience
- IVD, molecular diagnostics/NGS, and/or software product experience
- Previous experience with document/change control processes
- ASQ certification (e.g., CQPA, CQIA, CQE, CQA, CQT)
- Knowledge, Skills, and Abilities:
- Deep understanding of ISO 13485 and FDA QSR (21 CFR Part 820)
- Experience working in a regulated environment
- Bring a team spirit and problem-solving attitude
- Competent in use of Microsoft Office software (Word, Project, Excel, Visio, PowerPoint)
- Familiarity with SAP or analogous Enterprise Resource Planning software systems, Qualtrax electronic document system, CAPA software systems, and quality improvement processes
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What We Do
Pillar Biosciences was founded in 2014, on the principle that in order for personalized medicine to be realized, clinical Next Generation Sequencing (NGS) workflows need to be affordable, rapid, robust, and flexible. We’re focused on productive solutions that enable streamlined workflows, so that labs can generate dependable results with less inputs, less labor, and less time. Our team makes precision medicine practical through simple, efficient sequence enrichment technology and straightforward bioinformatics tools broadly available to molecular labs worldwide.
Why Work With Us
Our company was built on the foundational idea that a more collaborative approach to clinical NGS can help make precision medicine accessible for a wider range of laboratories. Join us if you're looking to join the genomic revolution in the clinical testing marketing and you want your ideas and contributions to have a significant impact.
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