Document Control Supervisor

Santa Ana, CA - USA

Yearly Salary: $ 82353 - 107363

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Department:

Document Control

Job Summary

Position Overview

Position Description

We are hiring a Document Control Supervisor. The Document Control Supervisor will process and monitor controlled document activities through Document Control systems. They will also assign work and monitor performance of the Document Control and Labeling personnel.

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:

Supervise Document Control Staff providing work direction and feedback on performance.
Provide department metrics reporting and performance against Key Performance Indicators KPIs
Manage and help to maintain and process Document Change Requests (DCRs) for all controlled documents.
Provide MasterControl Admin Support and Training support to all company personnel as needed.
Manage and maintain Inventory of controlled records and coordinate shipment to off-site storage location.
Support Quality Department during routine internal/external audits.
Manage and support team with the creation/revision/printing/obsoletion of Label Masters product inserts (IFUs) and other controlled documents
Manage and support team with employee training records within EDMS and paper copies.
Other duties as assigned

Required Skills/Education:

Bachelors Degree
At least 4 (four) years relevant experience in a quality function within medical device or regulated industry. Preferably document control.
Previous supervisory or lead experience required.
Excellent Computer skills specifically MS Word Excel Outlook
Experience working with eQMS preferably MasterControl managing entering report writing
Graphic design knowledge a plus.
Current industry regulations e.g. cGMP ISOCFR820 MDD 93/42/EEC IVDD 98/79/EC
Ability to speak write and read English.
Good oral and written communication skills.

Salary and Benefits:

For California the base salary range for this position is $82353 - $107363 annually. Compensation for the successful candidate will depend on various factors (e.g. qualifications education prior experience location etc.).
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 ().

Required Experience:

Manager

Position OverviewPosition Description We are hiring a Document Control Supervisor. The Document Control Supervisor will process and monitor controlled document activities through Document Control systems. They will also assign work and monitor performance of the Document Control and Labeling personn...