FUJIFILM Biosciences · 2 hours ago
QA In-Process Inspection Lead
Santa Ana, CA
Full-time
Onsite
Entry, Mid Level
$24.93/hr - $32.26/hr
2+ years expFUJIFILM Biosciences is dedicated to advancing life sciences through innovative products and services. The QA In Process Inspector Lead will oversee product inspections and ensure quality by managing manufacturing issues and coordinating with QA teams to release batch records post production.
BiotechnologyManufacturing
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
Qualification
Required
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
Preferred
Bachelor's Degree in a science discipline preferred
Benefits
Medical, Dental, Vision
Life Insurance
401k
Paid Time Off
Company
FUJIFILM Biosciences
With a foundation in cell culture that dates back to 1970, FUJIFILM Biosciences is a global, full spectrum supplier to the life sciences market, providing products and services that assist customers in advancing healthcare initiatives.
501-1000 employees
H1B Sponsorship
FUJIFILM Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Mayasari Lim
Associate Director, Custom Business
Recent News
EIN Presswire
2025-10-15
Company data provided by crunchbase