What are the responsibilities and job description for the Quality Assurance Specialist, Operations position at FUJIFILM Diosynth Biotechnologies?
Job Title: QA Specialist, Operations (Night)
Working Schedule: 1800-0600 in a 2-2-3 cadence
Location: Holly Springs, NC, USA
Company: FUJIFILM Diosynth Biotechnologies
Position Overview
FUJIFILM Diosynth Biotechnologies is seeking a QA Specialist, Operations, to join our growing team at our state-of-the-art Life Science Manufacturing Facility in Holly Springs, NC. The QA Specialist will provide Quality Assurance oversight for Drug Substance Manufacturing (DSM) processes during a 12-hour overnight shift. This role ensures that DSM systems and processes operate effectively, with a focus on consistent policy administration, real-time issue resolution, and QA oversight of activities during the shift.
Key Responsibilities
As the QA Specialist, you will:
- Provide QA oversight during the 12-hour overnight shift, supporting DSM operations in compliance with governing processes and procedures.
- Perform QA support activities, including:
- Reviewing Batch Records and Solution Lot Records with exception-based oversight using the Quality Review Management tool.
- Triaging real-time events and implementing immediate responses to deviations.
- Overseeing area changeovers and return-to-service activities.
- Providing real-time Work Order oversight in accordance with applicable procedures.
- Ensure department objectives are met within timelines or identified KPIs.
- Contribute to the development of QA documentation, procedures, and processes for operational readiness and manufacturing operations in a cGMP-regulated facility.
- Perform other duties as assigned.
Minimum Requirements
- Bachelor’s or Master’s degree in Life Sciences, Engineering, or equivalent:
- BS/BA: 2 years of relevant experience.
- MS: 0 years of relevant experience.
- 1-3 years of 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 or a similar role.
- Working knowledge of:
- ASTM E2500 standards.
- Smartsheet, Trackwise, MasterControl, and/or Kneat validation software.
