Specialist, Quality Assurance

Fujifilm • Research Triangle Park, NC

2d • Onsite

About The Position

The QA Operations Specialist is responsible for providing quality oversight of the day-to-day manufacturing operations for Drug Substance Manufacturing. This is primarily achieved through record and data review, area inspection, and incident resolution. 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.”

Requirements

• High School Diploma or Equivalent with 9 years of applicable industry experience OR Associates degree with 7 years of applicable industry experience OR Bachelor's degree with 5 years of applicable industry experience OR Master's degree with 3 years of applicable industry experience
• Strong verbal and written communication skills to partner with different teams and stakeholders
• Strong time management skills: ability to meet tight deadlines and ensure effective prioritization of tasks
• Excellent oral and written communications skills and fluency in English
• Fundamental knowledge and application of cGMP compliance and other related regulations
• Ability to understand complex SOPs/policies, and apply them appropriately in a variety of tasks
• Awareness of GAMP5, ALCOA++, Data Integrity, and application of 21 CFR Part 820 and Part 11
• Understanding of cell culture, fermentation, recovery and/or downstream processes
• Team based attitude and ability to build relationships, and communicate effectively with others
• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment
• Must be flexible to support 24/7 manufacturing facility

Nice To Haves

• Experience with Trackwise, SAP, Kneat and/or Veeva

Responsibilities

• Reviews executed batch and formulation records, ensuring production activities were performed as required and documentation meets requirements.
• Reviews electronic audit trails for manufacturing instruments and equipment, identifying orphan data and other anomalies.
• Provides compliance oversight of the manufacturing facility, including area inspections and changeover confirmations.
• Acts as quality resource for manufacturing personnel, especially pertaining to documentation and area readiness.
• Documents findings in the quality system and supports resolution.
• Manages assigned workflows to ensure all required timelines are met and escalates if work is off-track.
• Performs other duties as assigned.

Benefits

• medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions.
• industry leading 401(k) savings plan
• insurance coverage
• employee assistance programs
• various wellness incentives
• paid vacation time, sick time, and company holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED