QA Associate 1, Document Control

Fujifilm

Posted on : 24-05-2025

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1 Vacancy

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Job Location

Morrisville, NC - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 24-05-2025

Job Description

Position Overview

The Quality Assurance (QA) Associate 1 Document Control is an entry level position supporting the implementation and ongoing maintenance of the Document Management System (Veeva Vault) including scanning and uploading paper-based records. This role includes creating and maintaining Logbooks verifying records for compliance and providing document management and audit support. Additionally this role aids in ensuring that all documentation is compliance accurate and adheres to regulatory standards.

Company Overview

At FUJIFILM Diosynth Biotechnologies U.S.A. were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Diosynth Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

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

What Youll Do

Supports issuing and reconciling paper Master Logbooks to ensure data integrity and compliance with Food & Drug Administration (FDA) and other regulations
Assists with issuing verifying and reconciling Batch and Formulation Records as assigned
Reviews documents for completeness legibility and alignment with established quality standards
Uploads paper records including Good Manufacturing Practice (GMP) documents as electronic files to SharePoint and/or Veeva Vault Electronic Document Management System (EDMS)
Maintains physical and electronic filing systems in compliance with Good Documentation Practice (GDP)
Participates in routine audits of document systems as directed
Follows standard operating procedures (SOPs) and remains up-to-date and compliant with all required training
Collaborates with Quality Control (QC) Manufacturing and other stakeholders to ensure timely documentation updates
Performs other duties as assigned

Knowledge and Skills

Effective communication both written and oral
Ability to collaborate with coworkers and internal clients
Ability to manage and complete tasks according to a structured plan
Organizational and detail-orientated skills
Basic working knowledge of Veeva Vault MasterControl and/or SharePoint
Must be flexible to support 24/7 manufacturing facility including on-call as needed

Basic Requirement

High School Diploma/GED with 1-2 years of clerical or office administration experience; or
Associates degree in a related field with 0-1 years of clerical or office administration experience

Preferred Requirements

2 years of clerical or office administration experience
Experience with EDMS such as SharePoint MasterControl or Veeva Vault
Experience with Microsoft Office (e.g. Word Excel Teams etc.)

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. No X Yes

Ability to ascend or descend ladders scaffolding ramps etc. No X Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. No X Yes 120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes 10 lbs. X 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. No X Yes

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:

Employment Type

Unclear

Company Industry

Key Skills

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About Company

Fujifilm

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QA Associate 1, Document Control

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

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