QA Specialist, Drug Substance Manufacturing Operations

Fujifilm • Holly Springs, NC

18h • 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. The specialist provides QA oversight of day-to-day activities and supports resolution or mitigation of issues that arise during operations.

The position 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. It is based in the Holly Springs, North Carolina manufacturing environment. Occasional domestic and/or international travel may be available.

Requirements

• Bachelor’s degree in Life Sciences or Engineering, or equivalent, and 2 or more 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.
• Basic knowledge and application of cGMP compliance and related regulations.
• Understanding of GAMP5, Data Integrity, and the 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, and the ability to partner with different teams and stakeholders.
• Strong time-management skills and ability to meet tight deadlines and prioritize tasks effectively.
• Team-based attitude, ability to build relationships, and ability to communicate effectively with others.
• Collaborative attitude and willingness to work with global peers and cross-functional teams toward company and department goals.
• Ability to support a 24/7 manufacturing facility and work the stated 2/2/3 schedule from 6 a.m. to 6 p.m.

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.
• Occasional domestic and/or international travel may be available.

Responsibilities

• Provide QA oversight and support DSM operations in accordance with governing processes and procedures.
• Provide QA support for tasks including 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 according to applicable procedures.
• Ensure department objectives are met within desired timelines and/or identified KPIs.
• Contribute to developing 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