The Quality Systems Specialist is responsible for contributing to all aspects of planning, and implementing the Pillar Quality Management System. The role will allow the candidate to participate in Quality Systems (e.g. change control, document control, internal audits, CAPA), Design Assurance (e.g., product risk management, new product introduction), and Manufacturing Quality (nonconformities, process improvement) activities.
Opportunities will be available for the candidate to take on additional areas of responsibility based on interest. The candidate must be motivated, a quick-learner, and have the ability to work under minimal supervision. While the work is plentiful and challenging, the atmosphere is friendly and relaxed; a sense of humor is appreciated.
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 SOPsGenerate metrics for critical-to-quality processParticipate in internal and external audits as requiredAssist and collaborate with other department such as Manufacturing, Quality Control, Clinical Affairs, and Regulatory to ensure continued compliance, product quality, and safetyAddress issues related to quality concerns, implementing effective solutions and corrective actionsReview 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 field1 to 3 years QA experience in an ISO 13485 Certified or FDA regulated companyTechnical/Procedure writing, and process mapping experienceIVD, molecular diagnostics/NGS, and/or software product experiencePrevious experience with document/change control processesASQ 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 environmentBring 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
This position is conducted in a hybrid-office environment. Must be able to perform work while sitting or standing for long periods of time. Work may at times require repetitive movements.
Pillar Biosciences aims to "Make precision medicine the first option for every patient" by developing and manufacturing targeted next-generation sequencing (NGS)-based assays and software for today’s high-throughput specialty NGS laboratories. We are seeking collaborative and independent problem solvers to support our mission.
Pillar Biosciences is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; religion; age; nationality; marital status; sexual orientation; disability or any other characteristic protected by law.
