Analyst, QA PQS
About The Position
The QA Analyst, PQS assists in the quality oversight of PQS applications for the Enterprise Quality Systems administration and document control. The QA Analyst, PQS collaborates within the team as well as with other project teams on-site, and with QA departments at other FDB sites. This role focuses on consistent policy administration, assists QA oversight of daily activities, and resolves or mitigates issues that occur during operations. This role maintains relationships with site-based customers and global colleagues, and provide updates as requested. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. 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
Requirements
- Bachelor’s Degree in Life Sciences (e.g., Engineering, Applied Science or Chemistry) with 0-1 years of experience
- Basic experience or understanding of GMP, GLP, GDP requirements
Nice To Haves
- Prior experience in GMP environment
- Previous quality systems experience
Responsibilities
- Supports QA for project deliverables in accordance with the governing processes and procedures within the assigned Quality area
- Participates in assigned audits on a regular basis
- Identifies, evaluates, and owns continuous improvement opportunities for the assigned quality area
- Maintains quality oversight of quality systems owned by the assigned quality area
- Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness and through cGMP operations
- Uses discretion to make informed quality related decisions for the quality systems area
- Actively supports quality decisions that may impact operations, ensuring appropriate escalation
- Applies knowledge and skillset to be SME for support functionality such as Tableau
- Monitors procedures, and reports and processes
- Documents and communicates areas of concern, deviations, CAPA etc
- Participates in risk assessments and assists in mitigating quality-related risks
- Provides administrative support for quality systems, as required
- Performs other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
