QA Specialist, Drug Substance Manufacturing Operations

Fujifilm • Holly Springs, NC

4d • Onsite

About The Position

The QA Specialist, Drug Substance Manufacturing Operations (DSM) partners in Quality oversight of Drug Substance Manufacturing processes. The role oversees execution of validation programs to help ensure applicable DSM systems and processes are operated and maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. It provides QA oversight of day-to-day activities and supports resolution or mitigation of issues during operations.

The position supports DSM operations in a cGMP-regulated manufacturing facility and contributes to operational-readiness documentation, procedures, and processes. It also participates in efficiency and streamlining initiatives with other FUJIFILM Biotechnologies sites. The role supports a 2/2/3 schedule from 6 a.m. to 6 p.m. and must be flexible to support a 24/7 manufacturing facility. Occasional domestic and/or international travel may be available.

Requirements

• Bachelor’s degree in Life Sciences or Engineering, or equivalent, with at least 2 years of relevant experience; alternatively, a master’s degree in Life Sciences or Engineering, or equivalent, with 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.
• Strong verbal and written communication skills and fluency in English.
• Strong time management skills and ability to prioritize tasks and meet tight deadlines.
• Basic knowledge and application of cGMP compliance and related regulations.
• Understanding of GAMP5, data integrity, and application of 21 CFR Part 820 and Part 11.
• Understanding of cell culture, upstream processes, large-scale recovery, and/or downstream processes.
• Team-based attitude and ability to build relationships and communicate effectively.
• Collaborative attitude and willingness to work with global peers and cross-functional teams toward company and department goals.
• Flexibility to support a 24/7 manufacturing facility.

Nice To Haves

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

Responsibilities

• Provide QA oversight and support DSM operations in accordance with governing processes and procedures.
• Provide QA support for batch record and solution lot record review, including exception-based oversight using the Quality Review Management tool.
• Triage events in real time and implement immediate responses to identified deviations.
• Provide oversight of area changeover and return to service.
• Provide real-time work order oversight according to applicable procedures.
• Ensure department objectives are met within desired timelines and/or according to identified KPIs.
• Contribute to development of QA documentation, procedures, and processes for operational readiness and QA support of manufacturing operations in a cGMP-regulated facility.
• Participate in streamlining or efficiency-improvement initiatives with other FUJIFILM Biotechnologies sites.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level