QA Engineer, Drug Product - Second Shift
About The Position
The QA Operations Engineer supports Quality oversight of Drug Product manufacturing areas and processes during the assigned shift. The position collaborates with the Drug Product Quality team and cross-functional teams to ensure systems and processes are operated and maintained as intended, with consistent policy administration, QA oversight of shift activities, and resolution or mitigation of operational issues. The role serves as a subject matter expert within the QA team, developing documents, processes, and procedures for the Drug Product program. It generates, reviews, and approves QA documentation and provides QA support for operational readiness and manufacturing operations in a cGMP-regulated facility. Responsibilities also include shop-floor support, oversight of change management and lifecycle documentation, and helping maintain manufacturing systems in a validated state through startup and commercial operation. The position initially works a Monday–Friday, 3:00 p.m.–11:30 p.m. schedule and is expected to transition to a rotating 2-2-3, 12-hour schedule. The role supports 24/7 operations and may require nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned. Shift differential eligibility is subject to Company policy. The position is based at FUJIFILM Biotechnologies’ facility in Holly Springs, North Carolina. Work may take place in warm or cold environments, including 2–8°C conditions, and involves the physical activities described in the posting.
Requirements
- Bachelor’s degree with 5 years of related experience, or a master’s degree with 3 years of related experience.
- Experience working in a regulated GMP environment.
- Strong verbal and written communication skills to work with different teams and stakeholders.
- Strong time-management skills and ability to prioritize tasks and meet tight deadlines.
- Ability to adapt and adjust plans in a fast-paced environment.
- Critical thinking, problem-solving, organization, and planning skills.
- Team-based attitude and ability to build relationships and communicate effectively.
- Knowledge of technology transfer and/or product commercialization processes.
- Familiarity with hygienic utilities, quality systems, automation, manufacturing and IT systems, and validation of production equipment.
- Understanding of data integrity and application of 21 CFR Part 820 and Part 11.
- Ability to work nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned.
- Ability to discern audible cues.
- Ability to inspect or perform tasks with 20/20 corrected vision, including visual acuity and color distinction.
- Ability to stand and sit for prolonged periods, up to 120 minutes.
- Ability to perform repetitive motions involving wrists, hands, and/or fingers.
- Ability to move objects weighing up to 10 pounds.
- Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.
Nice To Haves
- Understanding of formulation, aseptic filling, and/or visual inspection.
- Working knowledge and experience with Trackwise, Veeva, PAS-X, Smartsheet, and/or Kneat.
- Experience with startup projects.
- Training and/or familiarity with Quality Risk Management principles.
Responsibilities
- Serve as a subject matter expert within the QA team for developing Drug Product program documents, processes, and procedures.
- Generate, review, and approve QA documentation, procedures, and processes for operational readiness and manufacturing support in a cGMP-regulated facility.
- Provide manufacturing shop-floor support, including AQL, critical process-step verification, issue resolution, line clearance, alarm response, and work order oversight.
- Ensure project and operational quality objectives are met within required timelines.
- Assess the impact of system and process modifications and oversee change management to help maintain manufacturing systems in a validated state through startup and commercial operation.
- Oversee and approve system and process lifecycle documentation, including risk and impact assessments and product, process, and equipment specifications.
- Participate in optimization and improvement initiatives.
- Support regulatory agency and third-party inspections.
- Perform other duties as assigned.
Benefits
- Shift differential eligibility in accordance with Company policy.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
