QA In-Process Inspection Lead

Santa Ana, CA - USA

Hourly Salary: $ 24 - 32

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

Position Description

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

Company Overview

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 worlds 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 youre 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 70000 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: Description

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 (CoAs DBs 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.

Required Skills/Education:

Associates Degree required Bachelors 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.

Salary and Benefits:

For California the base salary range for this position is $24.93 - $32.26 per hour. Compensation for the successful candidate will depend on various factors (e.g. qualifications education prior experience location etc.).
Working hours 9pm-5am
Medical Dental Vision
Life Insurance
401k
Paid Time Off

*#LI-onsite

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Position OverviewPosition Description 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 coordinat...