QA Audit Supervisor - Fujifilm

Overview

FUJIFILM Irvine Scientific, Inc. is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific, Inc. has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation, reporting to FUJIFILM Holdings Corporation.

We are hiring a QA Audit Supervisor. The QA Audit Supervisor will coordinate and manage the programs for internal, supplier, customer and regulatory audits. This includes scheduling, communication, execution, and follow up of all actions associated with the audits.

External US

Responsibilities

• Plan, budget, coordinate auditors to ensure audit program is completed
• Manage and perform internal and supplier audits (on-site and paper) as needed
• Manage and performs supplier qualification and re-evaluation
• Manage maintenance of supplier files and documentation
• Manage customer/regulatory audits: communication, execution, follow and observation close out
• Collaborates with other departments to meet customer requests and other demands 

Required Skills/Education 

• High school diploma or equivalent; basic understanding of mathematics and chemistry necessary.
• Two years of college in a science discipline is preferred.
• A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent.
• A minimum of two years in quality auditing for medical device or pharmaceutical companies
• A minimum of two years in a managerial position
• Proficiency in current versions of MS Word, Excel
• Excellent communication and collaboration skills
• Current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, TGA, Brazil and inspection and auditing guidelines.
• Ability to speak, read, and write English.
• Good Oral and communication skills.

Salary and Benefits:

• For California, the base salary range for this position is $77,625 to $124,200 annually. 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

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.

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