Support implementation and maintenance of the Quality Management System, including document/change control, CAPA, audits, design assurance, manufacturing quality, process improvements, training, and cross-functional QA activities for NGS/IVD products.
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 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
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.
Top Skills
Microsoft Word,Microsoft Project,Microsoft Excel,Microsoft Visio,Microsoft Powerpoint,Sap,Qualtrax,Capa Software,Iso 13485,Fda Qsr (21 Cfr Part 820),Ngs,Ivd,Molecular Diagnostics
Pillar Biosciences, Inc. Natick, Massachusetts, USA Office
Our Headquarters are conveniently located off of Route 9 near a bustling area filled with various retail stores and restaurants.
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