"Alerted.org

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., we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s 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, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s 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 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll 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

+ Associate’s 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 to 15, 30, 120, 240 minutes)

Ability to sit for prolonged periods of time. No X Yes 120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

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 committed to 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 ([email protected]).

**Job Locations** _US-NC-Morrisville_

**Posted Date** _5 days ago_ _(5/21/2025 4:39 PM)_

**_Requisition ID_** _2025-34609_

**_Category_** _Quality Assurance_

**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_