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.