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FUJIFILM Cellular Dynamics, Inc · 3 months ago

QA In-Process Inspection Lead

US-CA-Santa Ana

Full-time

Onsite

Mid, Senior Level

$24.93/hr - $32.26/hr

2+ years exp

FUJIFILM Cellular Dynamics, Inc is a leader in life sciences, providing a range of products and services in cell culture and biotechnology. The QA In-Process Inspection Lead is responsible for ensuring product quality through inspections and collaboration with manufacturing teams, while overseeing the QA In-Process Inspectors and managing deviation activities.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

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

Quality AssuranceCGMPFDA QSR 820MicrobiologyChemistryISO13485ERP systemsMicrosoft WordMicrosoft ExcelMicrosoft PowerPointEnglish proficiencyCommunication skills

Required

Associates Degree required

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 Cellular Dynamics, Inc

Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.

Founded in 2004

Madison, Wisconsin, USA

51-200 employees

https://www.fujifilmcdi.com

H1B Sponsorship

FUJIFILM Cellular Dynamics, Inc 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

2023 (4)

2021 (1)

2020 (3)