QA Specialist, QC Compliance at FUJIFILM Holdings America Corporation

Holly Springs, NC 27540

About the Job

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About the Role

The QA Specialist, QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist 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. In operations, the role ensures that all 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. Additionally, this role participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.

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 Diosynth Biotechnologies sites to streamline processes and maximize efficiency.

This role and the associated responsibilities develop as the project matures, and startup activities evolve into operations.

Performs other duties as assigned.

Minimum Requirements

Bachelor’s degree in Life Sciences or Engineering with 2+ years of experience, OR

Master’s degree in Life Sciences or Engineering with 1+ year of experience.

1+ years of experience in GMP Quality Assurance and/or a similar role.

Experience in validation, cGMP manufacturing operations, and/or Quality oversight in an FDA-regulated facility.

Preferred Requirements

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 820 and Part 11

Working & Physical Conditions

Ability to stand for prolonged periods of time up to 30 minutes

Ability to sit for prolonged periods of time up to 120 minutes

Ability to conduct work that includes moving objects up to 10 pounds.

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email

FDBN_PNC@fujifilm.com

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.