QA Specialist, Drug Substance Manufacturing

Fujifilm • Holly Springs, NC

18h

About The Position

The QA Specialist, Drug Substance Manufacturing (DSM) partners in Quality oversight of Drug Substance Manufacturing processes. The role provides oversight of validation program execution to ensure applicable DSM systems and processes remain in a validated state throughout their lifecycle, with a focus on consistent policy administration. The position also provides QA oversight of day-to-day activities and supports resolution or mitigation of operational issues in a cGMP-regulated manufacturing facility.

The role supports DSM operations in accordance with governing processes and procedures, contributes to operational-readiness documentation and process development, and participates in efficiency initiatives with other FUJIFILM Biotechnologies sites. The position requires flexibility to support a 24/7 manufacturing facility; occasional international and/or domestic travel may be available.

Requirements

• Bachelor’s degree in Life Sciences or Engineering, or equivalent, with 2 or more years of relevant experience; alternatively, a master’s degree in Life Sciences or Engineering, or equivalent, with no required 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.
• 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.
• Strong verbal and written communication skills, including fluency in English.
• Strong time-management skills and ability to prioritize tasks and meet tight deadlines.
• Ability to build relationships and communicate effectively with others, including global peers and cross-functional teams.
• Collaborative, team-based attitude and ability to bring positive energy to a dynamic work environment.
• Flexibility to support a 24/7 manufacturing facility.
• Ability to discern audible cues; stand for up to 30 minutes, sit for up to 120 minutes, perform repetitive motions involving wrists, hands, and/or fingers, and move objects weighing up to 10 pounds.

Nice To Haves

• 2 or more 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.
• Training and/or familiarity with Quality Risk Management principles.

Responsibilities

• Provide QA oversight and support for DSM operations in accordance with governing processes and procedures.
• Support DSM tasks such as 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.
• Oversee area changeover and return to service.
• Provide real-time work order oversight in accordance with applicable procedures.
• Ensure department objectives are met within desired timelines and/or according to identified KPIs.
• Contribute to the development of QA documentation, procedures, and processes for operational readiness and manufacturing operations.
• 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