QA Specialist, Drug Substance Manufacturing Operations

Fujifilm • Holly Springs, NC

3d • 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 for relevant processes and systems to ensure they remain in a validated state throughout their lifecycle, with a focus on consistent policy administration. It also provides QA oversight of day-to-day activities and supports resolution or mitigation of operational issues.

The position supports DSM operations in accordance with governing processes and procedures, including review of batch and solution lot records, real-time event triage and immediate 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 participates in efficiency improvement initiatives with other FUJIFILM Biotechnologies sites. The role is based in a 24/7 manufacturing environment and supports a 2/2/3 schedule from 6 a.m. to 6 p.m.; 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 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.
• 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.
• Basic knowledge and application of cGMP compliance and related regulations.
• Team-based attitude, ability to build relationships, and effective communication with others.
• Collaborative attitude and willingness to work with global peers and cross-functional teams toward company and department goals.
• Positive energy and willingness to contribute to a dynamic work environment.
• 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 motions involving wrists, hands, and/or fingers; and move objects weighing up to 10 pounds.

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.
• Willingness and ability to travel domestically and/or internationally occasionally.

Responsibilities

• Provide QA oversight and support for DSM operations in accordance with governing processes and procedures.
• Review batch records and solution lot records, including exception-based oversight using the Quality Review Management tool.
• Triage real-time events 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 in accordance with identified KPIs.
• Contribute to the 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: Entry Level