QA Specialist, DSM (Project QA)

FUJIFILM Diosynth Biotechnologies; Holly Springs (NC); On-site; USD 55,000 - 90,000; Full time

Job summary

An established industry player is seeking a QA Specialist to join their dynamic team in Holly Springs, North Carolina. This role is pivotal in ensuring quality oversight for Drug Substance Manufacturing processes, where you will develop critical documents and procedures while collaborating with a passionate team. You'll engage in quality assurance activities, manage operational readiness, and contribute to efficiency improvements across multiple sites. Join a mission-driven organization that is at the forefront of biopharmaceutical manufacturing and make a significant impact in the life sciences sector.

Qualifications

• 2+ years of experience in a GMP environment required.
• Experience in validation and quality oversight in FDA-regulated facilities.

Responsibilities

• Develop QA documents and procedures for DSM programs.
• Provide QA oversight and support for DSM operations.
• Review batch records and manage changeovers.

Skills

GMP QA Experience

Validation Knowledge

Quality Oversight

cGMP Manufacturing

Documentation Skills

Education

BSc/BA in Life Sciences or Engineering

Master’s in Life Sciences or Engineering

Tools

Smartsheet

Trackwise

MasterControl

Kneat Validation Software

Job description

Join to apply for the QA Specialist, DSM (Project QA) role at FUJIFILM Diosynth Biotechnologies.

The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the quality oversight of DSM project processes. This role involves oversight of validation program execution for these processes and systems to ensure DSM systems and processes are operated and maintained in a validated state throughout their lifecycle, with a focus on policy administration. The QA Specialist ensures QA oversight of daily activities and addresses issues during operation.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO.

The work we do at FUJIFILM Diosynth Biotechnologies is vital. We are expanding our locations, capabilities, and teams, seeking passionate, mission-driven individuals to make a difference. Join us and help manufacture the next vaccine, cure, or gene therapy in partnership with leading biopharma companies worldwide. We foster a culture called Genki that fuels your passion, energy, and drive.

Join us

We are investing over $2 billion in a new large-scale manufacturing site in Holly Springs, North Carolina, to accelerate our Bio CDMO business. This site will be the largest end-to-end cell culture CDMO provider in North America, offering comprehensive solutions including drug substance manufacturing, automated fill-finish, assembly, packaging, and labeling services.

Job Description

What You'll Do

• Develop documents, processes, and procedures for the DSM program within the QA team.
• Generate, review, and approve QA procedures for validation and lifecycle documents of manufacturing systems.
• Provide QA oversight and support DSM operations following established processes and procedures.
• Review batch records and solution lot records, including exception-based oversight.
• Perform real-time event triage and respond to deviations.
• Manage area changeovers and return to service activities.
• Oversee work orders as per procedures.
• Ensure departmental objectives are met within timelines and KPIs.
• Contribute to QA documentation, procedures, and processes for operational readiness and manufacturing support in a cGMP facility.
• Participate in efficiency improvement initiatives across FUJIFILM sites.
• Perform other duties as assigned.

Minimum Requirements

• BSc/BA in Life Sciences or Engineering with 2+ years of relevant experience, or
• Master’s in Life Sciences or Engineering with 0 years of relevant experience.
• 1-3 years’ experience in a GMP environment.
• Experience in validation, cGMP manufacturing, and/or quality oversight in an FDA-regulated facility.

Preferred Requirements

• Over 2 years of GMP QA experience.
• Knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl, or Kneat validation software.

Working & Physical Conditions

Ability to discern audible cues, stand and sit for prolonged periods, perform repetitive motions, and handle objects up to 10 pounds.