We are hiring a QA Auditor. The QA Auditor performs and assists with supplier, distributor, and internal audits. They will be responsible for the coordination and completion of supplier qualifications, re-evaluation and maintaining the electronic supplier files.
Company OverviewFUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’s facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.
Job DescriptionResponsibilities
Plan and perform internal, distributor and supplier audits (on-site, paper, and remote)Coordinate with internal personnel and suppliers to schedule, execute and follow up with auditobservationsCollaborates with other departments to meet the audit response proposed timelinesPerforms supplier qualification and supplier re-evaluations.Maintains audit documentation and completion of audit observationsMaintains supplier files including, but not limited to qualification, re-evaluation, audit reports, and current ISO certification or applicable accreditations Assists with regulatory audits as neededRoutine review of supplier activity for potential Inactivation, future audits, and other actions such as SCARS initiation, or “For Cause Audit” Assist with the development or maintenance of annual audit schedulesTravel domestic and international as needed for supplier auditing
Required Skills/Education
BS/BA in Biology, Microbiology, or Chemistry preferred 2-3 years of QA experience in medical device or biopharmaceutical environmentProficiency in current versions of MS Word, ExcelExcellent communication and collaboration skillsAuditing Experience highly preferredCurrent industry regulations, i.e., Detailed understanding of 21 CFR211-cGMP, FDA QSR 820, IS013485, Canadian Medical Device Regulations, Brazil, EU and inspection and auditing Excellent computer skills including MS Word, Excel, Access, PowerPoint, Outlook, ERP/MRP system, Document control programsAbility to speak, read, and write proficiently in EnglishGood oral and written communication skills
Salary and Benefits:
For California, the base salary range for this position is $79,954 - $104,236. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).Medical, Dental, VisionLife Insurance401kPaid Time Off
*#LI-onsite
EEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com).
Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Application FAQsSoftware Powered by iCIMS
www.icims.com