QA Auditor
QA Auditor
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
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 reevaluation and maintaining the electronic supplier files.
Company Overview
FUJIFILM 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 assistcustomers in advancing healthcare initiatives. Working across discovery research cell and gene therapy reproductive medicineand cytogenetics as well as the largescale production of biotherapeutics and vaccines the Company istrusted by researchers manufacturers and cliniciansworldwide.For over 50 years FUJIFILM Irvine ScientificsMission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in itsproducts and custom solutions providing customers with the vital resources needed to enrich human lives through innovative accessible therapies. The Companysfacilities 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 centerin China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability ValuePlan 2030 for sustainable growth. FUJIFILM Irvine Scientific Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.
Job Description
Responsibilities
- Plan and perform internal distributor and supplier audits (onsite paper and remote)
- Coordinate with internal personnel and suppliers to schedule execute and follow up with audit
- observations
- Collaborates with other departments to meet the audit response proposed timelines
- Performs supplier qualification and supplier reevaluations.
- Maintains audit documentation and completion of audit observations
- Maintains supplier files including but not limited to qualification reevaluation audit reports and current ISO certification or applicable accreditations
- Assists with regulatory audits as needed
- Routine 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 schedules
- Travel domestic and international as needed for supplier auditing
Required Skills/Education
- BS/BA in Biology Microbiology or Chemistry required or equivalent science degree
- 23 years of QA experience in medical device or biopharmaceutical environment
- Proficiency in current versions of MS Word Excel
- Excellent communication and collaboration skills
- Auditing Experience highly preferred
- Current industry regulations i.e. Detailed understanding of 21 CFR211cGMP 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 programs
- Ability to speak read and write proficiently in English
- Good oral and written communication skills
- Able to travel 2030 of the time domestic and international
Salary and Benefits:
- For California the base salary range for this position is $79954 $104236. Compensation for the successful candidate will depend on various factors (e.g. qualifications education prior experience location etc..
- Medical Dental Vision
- Life Insurance
- 401k
- Paid Time Off
*#LIonsite
EEO Information
Fujifilm is committedto 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 Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .
Employment Type
Unclear
