FUJIFILM Holdings America Corporation · 2 hours ago
QA Specialist, PQS
US-NC-Holly Springs
Full-time
Onsite
Entry, Mid Level
2+ years expFUJIFILM Holdings America Corporation is focused on building the future of bioproduction in Holly Springs, North Carolina. The QA Specialist, PQS is responsible for overseeing the day-to-day activities of the Pharmaceutical Quality Systems team, providing quality oversight, and collaborating with site-based customers and global colleagues to ensure compliance with quality standards.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
Supports QA for project deliverables in accordance with the governing processes, and procedures within the assigned Quality area
Assesses the impact of system controls and process modifications and maintains oversight of change management processes
Provides Quality/GMP oversight and approval of assigned area/systems and processes lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
Reviews and approves QA procedures for the validation approach and lifecycle documents as assigned
Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of assigned area/systems in cGMP regulated facility
Ensures project and operational quality objectives are met within desired timelines
Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
Supports quality decisions that may impact operations, ensuring appropriate escalation
Identifies risks and communicates gaps for quality and GMP process/systems
Performs other duties, as assigned
Qualification
Required
BS/BA in Life Sciences or Engineering or equivalent with 2+ years of applicable industry experience OR
Masters in Life Sciences or Engineering with 0 years of applicable industry experience
1-3 years of experience in a GMP environment
Preferred
Prior experience working within a QA role preferred
Company
FUJIFILM Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation 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
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase