QA Specialist, Drug Substance Manufacturing

Fujifilm • Holly Springs, NC

4d • Onsite

About The Position

The QA Specialist, Drug Substance Manufacturing (DSM) partners in Quality oversight of Drug Substance Manufacturing processes. The role oversees validation program execution for processes and systems 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 specialist also provides QA oversight of day-to-day activities and supports the resolution or mitigation of issues that arise during operations.

The position supports DSM operations in accordance with governing processes and procedures, including batch and solution lot record reviews, real-time event triage and response to deviations, area changeover and return to service, and real-time work-order oversight. The specialist contributes to QA documentation, procedures, and processes for operational readiness and manufacturing support in a cGMP-regulated facility, and may participate in efficiency initiatives with other FUJIFILM Biotechnologies sites. The role requires flexibility to support a 24/7 manufacturing facility, and occasional domestic 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 no relevant experience required.
• 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.
• Ability to collaborate and build effective relationships with teams, stakeholders, 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, sit for up to 120 minutes, perform repetitive wrist, hand, and/or finger motions, and move objects 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 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 batch record and solution lot record review, including exception-based oversight using the Quality Review Management tool.
• Triage real-time events and implement immediate responses to identified deviations.
• Provide oversight for 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 identified KPIs.
• Contribute to QA documentation, procedures, and processes for operational readiness and 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