QA Specialist - QC Compliance

Position Overview

The QA Specialist, QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist, QC Compliance helps drive Quality oversight for the direction of all QC laboratory processes, from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other project teams and QA departments at other sites to align strategies and procedures. This role ensures QC laboratory systems and processes are operated and maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, as well as QA oversight of day-to-day activities and resolution or mitigation of issues. This role participates in optimization and improvement initiatives and supports regulatory agency and third-party inspections.

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

Job Description

What You’ll Do

• Provides QA oversight and support for project deliverables in accordance with the governing processes and procedures for the QC laboratory program.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure laboratory systems are first validated, and then maintained in a validated state through site startup and into commercial operation.
• Provides oversight and approval of laboratory system and process lifecycle documentation, including risk and impact assessments, 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 laboratory equipment and systems.
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of laboratory operations in cGMP regulated facilities.
• Ensures that project and operational quality objectives are met within desired timelines.
• Actively seeks opportunities to collaborate and align with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Excellent oral and written communications skills and fluency in English.
• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Understanding of GAMP5, USP <1058>, Data Integrity, and application of EU Annex 1, 21 CFR Parts 11 and 820 as pertains to lab processes.
• Understanding of validation of laboratory benchtop and support equipment, and methodologies.
• Knowledge and application of cGMP compliance and other related regulations.
• Strong communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to think critically and have superior problem-solving skills.
• Team-based attitude and ability to build relationships and communicate effectively with others.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 2+ years of experience; OR,
• Master’s degree in Life Sciences or Engineering with 0 years of experience.
• 1-3 years of experience in a GMP environment.
• 1+ years of experience in GMP Quality Assurance and/or similar role.
• Experience in validation, cGMP manufacturing operations, and/or Quality oversight in an FDA-regulated facility.

Preferred Qualifications

• Prior experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software.
• Basic experience or understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
• Prior experience and basic understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
• Prior experience or understanding of GAMP5, Data Integrity, and application of 21 CFR Part 280 and Part 11.
• Training and/or familiarity with Quality Risk Management principles.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is required on a regular basis to:

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 60 minutes.
• Ability to sit for prolonged periods of time for up to 60 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.

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.

*LI-Onsite

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]).