Quality Assurance Specialist, Validation

Position Overview

The QA Specialist, Validation, is responsible for helping to drive the Quality oversight for commissioning and qualification processes. This role is responsible for quality assurance oversight, review, and approval of validation activities and documents associated with new systems, changes to existing systems, maintaining the validated state of equipment/processes/systems, and decommissioning.

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:

Job Description

What You'll Do

• Performs a role within the QA team for the development of documents, processes, and procedures for the Validation program
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities and equipment
• Generates, reviews, and approves QA documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility
• Ensures project and operational quality objectives are met within desired timelines
• Manufacturing (Clean Room) shop floor support for issue resolution, as needed
• Participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections
• Must be flexible to support 24/7 manufacturing facility
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor's degree in Life Sciences or Engineering with 2 years of applicable industry experience OR Master's degree in Life Sciences or Engineering with no previous experience
• 1-3 years of experience working in a GMP regulated environment
• Experience in Validation and/or Quality oversight, in an FDA regulated facility

Preferred Requirements:

• Working knowledge and experience with ASTM E2500, Smartsheets, Trackwise, Veeva, and Kneat validation software
• Familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT
• Systems, and methodologies
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
• Understanding of Drug Substance, Drug Product and/or Finished Goods manufacturing processes
• Experience with startup projects or initiatives
• Training and/or familiarity with Quality Risk Management principles preferred
  

Working Conditions & Physical Requirements:

• Will work in environment which may necessitate respiratory protection. X No Yes
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
• Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
• Ability to discern audible cues. No X Yes
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).