QA Associate 1, Document Control Position Available In Wake, North Carolina

QA Associate 1, Document Control
Job Locations
US-NC-Morrisville
Posted Date
3 days ago
(5/22/2025 2:09 AM)
Requisition

ID 2025-34609

Category Quality Assurance Company (Portal Searching) Diosynth Biotechnologies
Position 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 forpliance, and providing document management and audit support. Additionally, this role aids in ensuring that all documentation ispliance, accurate, and ads to regulatory standards. Company At 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 biopharmaceuticalpanies, Diosynth Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMPpliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home w 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, vibrantmunities, 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.”

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fujifilmus/en/about/region/careers Job Description What You’ll Do Supports issuing and reconciling paper Master Logbooks to ensure data integrity andpliance with Food & Drug Administration (FDA) and other regulations
Assists with issuing, verifying, and reconciling Batch and Formulation Records, as assigned
Reviews documents forpleteness, legibility, and alignment with established quality standards
Uploads paper records, including Good Manufacturing Practice (GMP) documents as electronic files to Point and/or Veeva Vault Electronic Document Management System (EDMS)
Maintains physical and electronic filing systems inpliance with Good Documentation Practice (GDP)
Participates in routine audits of document systems, as directed
Follows standard operating procedures (SOPs) and remains up-to-date andpliant 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 Effectivemunication, both written and oral Ability to collaborate with coworkers and internal clients Ability to manage andplete tasks according to a structured plan Organizational and detail-orientated skills Basic working knowledge of Veeva Vault, MasterControl, and/or Point 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 Point, 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 ismitted to providing equal opportunities in hiring, promotion and advancement,pensation, 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 amodation inpleting this application, interviewing,pleting any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBUfujifilm). Options