Specialist, Quality Assurance

Position Overview

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.

Company Overview

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

Job Description

Major Accountabilities:

• 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.

Minimum Education and Experience 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

Knowledge, Skills or Abilities:

• 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

Preferred Education and Experience Requirements

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

Working Conditions & Physical Requirements: 

• Will work in environment which may necessitate respiratory protection
• Ability to stand for prolonged periods of time 
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to sit for prolonged periods of time.  
• Ability to stand for prolonged periods of time.  
• Ability to conduct work that includes moving objects up to 10 pounds.

Benefits

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with th