QA Specialist, Drug Substance Manufacturing

Fujifilm • Holly Springs, NC

3d

About The Position

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

The role supports DSM operations in a cGMP-regulated manufacturing facility, helps meet department objectives and KPIs, contributes to operational-readiness documentation and procedures, and participates in efficiency-improvement initiatives with other FUJIFILM Biotechnologies sites. Occasional domestic or international travel may be available. The employee must be flexible to support a 24/7 manufacturing facility.

Requirements

• Bachelor’s degree in Life Sciences or Engineering, or equivalent, with at least 2 years of relevant experience; or 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.
• Understanding of GAMP5, data integrity, and application of 21 CFR Part 820 and Part 11.
• Basic knowledge and application of cGMP compliance and related regulations.
• Understanding of cell culture, upstream processes, large-scale recovery, and/or downstream processes.
• Strong verbal and written communication skills and fluency in English.
• Strong time management skills and ability to prioritize tasks and meet tight deadlines.
• Ability to build relationships and communicate effectively with teams and stakeholders.
• Collaborative attitude and willingness to work with global peers and cross-functional teams.
• Flexibility to support a 24/7 manufacturing facility.
• Ability to discern audible cues; stand for up to 30 minutes and sit for up to 120 minutes; perform repetitive wrist, hand, or finger motions; and move objects weighing up to 10 pounds.

Nice To Haves

• 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.
• Training in or familiarity with Quality Risk Management principles.

Responsibilities

• Provide QA oversight and support for DSM operations in accordance with governing processes and procedures.
• Provide QA support for DSM tasks, including Batch Record and Solution Lot Record review and exception-based oversight using the Quality Review Management tool.
• Triage events in real time and implement immediate responses to identified deviations.
• Oversee area changeovers and return to service.
• Provide real-time work order oversight in accordance with applicable procedures.
• Ensure department objectives are met within desired timelines and according to identified KPIs.
• Contribute to the development of QA documentation, procedures, and processes for operational-readiness objectives and manufacturing operations.
• Participate in streamlining and 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