The QA Engineer, Pharmaceutical Quality Systems (PQS) Audits & Inspections is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) team. This role is primarily responsible for coordinating GMP customer audits and regulatory inspections and supporting the Quality Management Review on a local and global level.

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

What You'll Do

• Performs customer audits and regulatory inspections at FDBN (site Holly Springs) by:
     o Coordinates all preparation activities needed; supports audit execution as host,            scribe, prep lead (be member of the hosting team); follows up on observations,          coordinates timely actions from audit/inspection report and provides responses          on behalf of FDBN and follows up internally on actions
     o Seeks continuous improvement opportunities learned from audit/inspection                situations from the PQS process
• Ensures adequate quality systems are implemented across the business to meet regulatory and customer requirements
• Supports creation and maintenance of quality assurance policies for all our quality subsystems, including learning set up for PQS team. This may also involve global processes for the PQS
• Interfaces with Regulatory Affairs and Business Process Owners (BPOs) to develop robust compliance processes, implements quality system strategies and plans to facilitate continuous improvements of the PQS, and interprets and implements quality assurance standard in PQS
• Maintains professional working knowledge of relevant regulations, guidance documents and standards, and identify best practices within the company
• Provides QA oversight and support of project deliverables in accordance with governing processes, and procedures for the PQS
• Participates in data gathering and generation for site Quality Management Review and Global Quality Management Review
• Contributes to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Ensures project and operational quality objectives are met within desired timelines.
• Participates in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites
• Monitors processes for continuous improvement
• Independently leads continuous improvement projects related to systems, processes, and documentation
• Serves as QA subject matter expert for site processes, systems, and documentation as it relates to audits and inspections
• Performs other duties, as assigned

Minimum Requirements

• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR
• MS in Life Sciences or Engineering and 3+ years of applicable experience OR
• PhD in Life Sciences or Engineering with 1+ years of applicable experience
• 3+ 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 Requirements 

• Working knowledge of ASTM E2500, Smartsheet and/or Kneat validation software, TrackWise is preferred
• Experience and understanding of one or more of the following processes preferred:
     o cell culture or fermentation
     o large-scale recovery processes
     o formulation and/or aseptic filling
     o finished goods manufacturing

• Training and/or familiarity with Quality Risk Management principles preferred

Working & Physical Conditions

Ability to discern audible cues. 

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 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.

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.

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 (FDBN_PNC@fujifilm.com).