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, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The companys consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific 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 for a Quality Assurance Supervisor to Manage the Companys Quality Assurance personnel and activities including incoming QA inspection of raw materials and final products, raw material source and origin program, customer change notification, internal and supplier audit programs, deviation management and various customer and internal support as required.

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Responsibilities:

• Manage QA Incoming Inspection function and personnel

• Manage product Final Release function and personnel

• Manage raw material source and origin program including maintenance of data bases and records

• Manage supplier and internal audit program including scheduling, pre- and post-audit activities

• Manage and provide customer support in areas such as completion of surveys, providing raw material source and origin information, and related QA support

• Assist in activities related to the preparation for and conduct of FDA and Notified Body inspections and customer audits

• Assist and support Quality Systems management in the conduct of daily operations of the department and within the Company as required.

• Trend and Analyze Quality Indicators, deviations, actions, and other related KPIs to ensure efficient company function. Provide input as to appropriate corrective and preventive actions and suggest plans for improvement.

• Support Operation Excellence program by taking actions identified during the Quality Indicator

Experience/ Education:

• BS. in Microbiology/Chemistry/Biology/Chemical Engineering or equivalent experience preferred

• Five or more years of direct QA experience in the medical device and/or pharmaceutical industry

• 2 years of supervisory experience

• Proficiency in current versions of MS Word, Excel

• Excellent communication and collaboration skills

• Detailed knowledge of FDAs GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada, and MDR requirements

• Ability to speak, read, and write English

• Good Oral and communication skills

• The employee frequently is required to read, compile, compute, and record numerical and statistical data

• Must be able to lift up to 20 lbs

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.

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.

If COVID-19 vaccine is mandated by the federal government, or by state or local government, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

Requisition ID: 2022-21527

External Company URL: [ Link removed ] - Click here to apply to Quality Assurance Manager

Street: 1830 E Warner Ave