We are hiring a Quality Assurance Support Specialist. The QA Support Specialist will support external and internal requests for quality information. The person in this role will help to manage change notifications, surveys, qualifications, supplier management, audit corrective actions, and management of customer support related to Quality related questions. In addition, this person will ensure that customers obtain needed information to continue their process, and that required quality exists in audits and non-conformance program as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, and Health Canada MDR requirements.
Help customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc.)
Acts as customer liaison for internal inquiries and provide voice of customer
Coordinates customer surveys and questionnaires completion
Assist with supplier questionnaires and qualification
Assist with customer audits and follow up actions
Assist with change notification and supplier management
Assist with batch record review or other duties as needed
Assist with coordination of quality activities for related FISI production sites
BS/BA in Biology, Microbiology, or Chemistry preferred
3-5 years of QA experience in medical device or biopharmaceutical environment
Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements.
Excellent computer skills including MS Word, Excel, PowerPoint
Ability to speak, read, and write proficiently in English
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.