QA Audit Specialist - FISI - FUJIFILM Irvine Scientific

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 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.

We are hiring a QA Commercial Specialist. The QA Commercial Specialist is responsible for Coordinating/Scheduling customer and regulatory Inspections and audits. Co-host inspections and audits with QA Commercial Manager. Assists with audit and observation closure. Coordinates and assists internal/external customers with quality related questions, questionnaires, statements, certificates and other related inquiry resolution.  Assists with and coordinates material qualifications, change notifications and change assessments.

External US

Responsibilities

• Coordinate preparation for and assist in hosting customer and regulatory audits; scheduling, follow up, planning, observation closure and related activities.
• Manage audit calendar.
• Input audit report and findings into MasterControl or other tracking systems as needed. Maintain and update audit files, databases, and notes.
• Collaborate with other departments to meet the audit response proposed timelines, observation closures, and related activities.
• Respond and fulfill customers' requests for information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, statements, follow up, etc... ).
• Act as customer liaison for internal/external inquiries and provide voice of customer
• Complete requested surveys and questionnaires.
• Assist with material qualifications, change assessment, change notification and supplier management.
• Other duties as assigned.

 Required Skills/Education 

• High school diploma or equivalent; two years of college in a science discipline is preferred.
• 2-3 years of QA experience in medical device or biopharmaceutical environment.
• Proficiency in current versions of MS Word, Excel, Outlook.
• Excellent communication and collaboration skills
• Auditing experience highly preferred.
• Excellent organization and follow up skills.
• Ability to speak, read, and write proficiently in English.
• Good oral and written communication skills.
• Current industry regulations, i.e., Understanding of cGMP, FDA QSR 820, IS013485,Canadian Medical Device Regulations, Brazil, EU and inspection and auditing guidelines.
• Excellent computer skills including MS Word, Excel, PowerPoint, Outlook, ERP/MRP system, Document control programs.

Salary and Benefits:

• $22.78 - 29.61 per hour depending on experience
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

EEO/AGENCY NOTES

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.

*#LI-Onsite