QA Specialist, DSM Operations

About the Role

The QA Specialist, DSM Operations (Days 2-2-3 0600-1800) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, DSM Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."

Responsibilities

• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures.
• Provides QA support of DSM tasks such as: Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool.
• Real time event triage and implementation of immediate response to identified deviations.
• Area changeover and return to service.
• Real time WO oversight per applicable procedures.
• Ensures 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 objectives and QA support of manufacturing operations in cGMP regulated facility.
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites.
• Works a 12-hour shift on 2-2-3 cadence, 0600-1800.
• Perform other duties, as assigned.

Qualifications

Minimum Requirements:

• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience; OR, Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience.
• 1-3 years' experience in a GMP environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Preferred Requirements:

• 2+ years of experience in GMP Quality Assurance and/or 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.

Skills

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Basic knowledge and application of cGMP compliance and other related regulations.
• Excellent oral and written communications skills and fluency in English.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 required.
• Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
• Team based attitude and ability to build relationships and communicate effectively with others.
• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Occasional opportunity for International and/or Domestic travel may be available.
• Must be flexible to support 24/7 manufacturing facility.

Working Conditions & Physical Requirements

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time, up to 30 minutes.
• Ability to sit for prolonged periods of time, up to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.