FUJIFILM Biotechnologies · 3 hours ago
QA Specialist, DSM (Project QA)
Holly Springs, NC
Full-time
Onsite
Entry, Mid Level
2+ years expFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for quality oversight of DSM project processes, ensuring that systems and processes are maintained in a validated state throughout their lifecycle.
BiotechnologyHealth CareManufacturing
Responsibilities
Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program
Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
Provides QA oversight and supports DSM operations in accordance with governing processes and procedures
Provides QA support of DSM tasks such as
Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool
Real time event triage and implementation of immediate response to identified deviations
Area changeover and return to service
Real time WO oversight per applicable procedures
Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs
Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites
Perform other duties, as assigned
Qualification
Required
BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR
Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience
1-3 years' experience in a GMP environment
Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
Preferred
2+ years of experience in GMP Quality Assurance and/or similar role
Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
Company
FUJIFILM Biotechnologies
For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.
Founded in 2011Morrisville, North Carolina, USA
1001-5000 employees
H1B Sponsorship
FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Lars Petersen
President & Chief Executive Officer
Morten Munk
Director - Global Alliance Management
Recent News
Morningstar.com
2025-10-30
Company data provided by crunchbase