QA In-Process Inspection Lead

Fujifilm•Santa Ana, CA

12d•$25 - $32•Onsite

About The Position

We are hiring a QA In Process Inspector Lead . The QA In Process Inspector Lead will ensure quality of product by performing and overseeing inspections of product, personnel, and processes real time with manufacturing production. They will collaborate and coordinate manufacturing issue resolution, through questions, meetings, documentation and follow up of actions and review, obtain corrections, and completed actions to release batch records post production. THIS ROLE WILL WORK 3rd SHIFT 9pm-5am At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences). Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Associates Degree required, Bachelor’s Degree in a science discipline preferred.
Basic understanding of microbiology and chemistry necessary.
A minimum of two (2) years of Quality Assurance (record review or incoming inspection) in medical device manufacturer or equivalent.
Computer skills necessary including Microsoft Word, Excel, PowerPoint, ERP systems.
Detailed understanding of Current industry regulations, i.e. cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, inspection guidelines, and general lab safety.
Ability to speak, read, and write English.
Good oral and communication skills.

Responsibilities

Provide work direction to and supervision of the QA In-Process Inspectors.
Perform inspection activities (product, performance, training) in the manufacturing areas
Convene and coordinate deviation management activities
Follow and enforce GMP principles and company policies and procedures throughout the organization
Perform and coordinate with QA In-Process Inspectors facility walkthroughs to ensure company procedures are followed report any deviation immediately to department management.
Built a collaborative and communications report with operations management
Attend daily production meetings and address production issues and report accordingly
Review batch production records and perform associated activities (CoA’s, DB’s, error correction)
Inspect labeling and storage conditions of product
Assist in the updating of controlled documents (generating DCRs as needed)
Reviews and provide proposals for processes improvements as needed
Maintain and update raw material inspection report database and prepare reports as assigned.
Work independently and have effective communication skills.
Accept/reject materials based on specifications.
Assist/perform the release of final product.