Sr. QA Technical Specialist
About The Position
The Senior QA Technical Specialist acts independently and provides QA subject matter knowledge in the GMP domain to systems and projects with focus on key quality activities and deliverables in accordance with company policies/SOPs and regulatory requirements. Works closely with project teams and stakeholders across the organization, support development and maintenance of computerized system and data integrity PQS subsystems. At FUJIFILM Biotechnologies, 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 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
Requirements
- High School Diploma or Equivalent with 12 years of applicable industry experience OR
- Bachelor’s degree with 8 years of applicable industry experience OR
- Master’s degree 6 years of applicable industry experience OR
- PhD with 4 years of applicable industry experience
- Solid GMP knowledge
Nice To Haves
- QA and/or manufacturing expeirence from the pharmaceutical industry
Responsibilities
- Review and approval of validation documentation against PQS subsystems Computerized Systems and Data Integrity processes and requirements.
- Review and approval of qualification documentation against PQS subsystems Computerized Systems and Data Integrity processes and requirements.
- Review and approval of changes, events/deviations, incidents, CAPAs etc. (process records) as well as procedural documents in relation to computerized systems.
- General inspection and audit support in relation to computerized systems.
- Develop and maintain the PQS framework related to computerized systems and based on current GMP and other relevant regulatory requirements (per global policies).
- Meet internal training requirements (per assigned training curricula) and keep oneself up to date on current GMP and other relevant regulatory requirements as well as relevant guidelines for computerized systems
- This position has interactions to Engineering as well as all other QA functions locally and globally.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
