Specialist, QA Operations

Position Overview

The QA Specialist Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle with a focus on consistent policy administration. The QA Specialist Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll Do

• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures.
• Provides QA support of DSM tasks such as:
  • Batch Record and Solution Lot Record review including exception-based oversight using Quality Review Management tool.
  • Real time event triage and implementation of immediate response to identified deviations.
  • Area changeover and return to service.
  • Real time WO oversight per applicable procedures.
• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs.
• Contribute to the development of QA documentation procedures and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites.
• Perform other duties as assigned.

Knowledge Skills and Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management ability to meet tight deadlines to ensure effective prioritization of tasks.
• Basic knowledge and application of cGMP compliance and other related regulations.
• Excellent oral and written communications skills and fluency in English.
• Understanding of GAMP5 Data Integrity and application of 21 CFR Part 820 and Part 11 required.
• Understanding of cell culture upstream processes large scale 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.
• Collaborative attitude with the willingness to work with global peers and cross functional teams toward company and department goals.
• Occasional opportunity for International and/or Domestic travel may be available.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• BS/BA in Life Sciences or Engineering or equivalent with 2 years of relevant experience; OR
• Masters in Life Sciences or Engineering or equivalent with 0 years relevant experience.
• 1-3 years experience in a GMP environment.
• Experience in Validation cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.

Preferred Qualifications

• 2 years of experience in GMP Quality Assurance and/or similar role.
• Experience and working knowledge of ASTM E2500 Smartsheet Trackwise MasterControl and/or Kneat validation software.

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 30 minutes.
• Ability to sit for prolonged periods of time for 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 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 committedto 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 ().

Required Experience:

IC