QA Engineer, Drug Substance

Merck & Co.; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC, seeks a QA Engineer for Drug Substance to oversee quality across manufacturing, testing, and distribution, ensuring adherence to cGMP and GDP. You will guide Manufacturing, Quality Control, and Facilities staff, supporting audits and inspections.

The role emphasizes coaching, issue resolution, and driving continual improvements within QA and manufacturing processes in a multi-disciplinary setting.

Qualifications

• Bachelor's degree in Life Sciences or Engineering with 5+ years of applicable industry experience; OR Master’s with 3+ years; OR PhD with 1+ year.

Responsibilities

• Provide quality oversight to ensure Drug Substance is manufactured, tested, stored, and distributed per cGMP and GDP.

Skills

Regulatory knowledge

cGMP biotech manufacturing

Cross-functional collaboration

Excellent communication

Attention to detail

Problem solving

Mentoring

GAMP5 knowledge

21 CFR Part 820/11

MES/Automation familiarity

Education

Bachelor's in Life Sciences or Engineering

Master's in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

Trackwise

Veeva

Kneat

Job description

Position Overview

The QA Engineer, Drug Substance will serve as a Quality Assurance Specialist responsible for manufacturing quality assurance, working directly with Manufacturing staff during drug substance operations to support real-time decisions on quality requirements and deviations. This role fosters strong partnership and knowledge sharing between Manufacturing and Quality teams while providing coaching, guidance, and direction to Manufacturing, Quality Control, Supply Chain, and Facilities & Engineering staff on compliance, quality systems, day-to-day QA oversight, and issue resolution or mitigation. Additionally, this role participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.

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. Ready to shape the future of medicine? Let's transform healthcare together!

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." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

• Responsible for providing Quality oversight to ensure that Drug Substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Fujifilm requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA).
• Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent manufacturing QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
• Collaborative attitude with the willingness to work with global peers and cross-functional teams to build strong partnerships, influence compliant operations, and achieve company and department goals.
• Excellent oral and written communications skills and fluency in English.
• Attention to detail with strong organizational skills and a commitment to maintaining quality standards while following assignments through to completion.
• Problem solving & conflict resolution.
• Provide source of knowledge and possess ability to mentor job duties for less experienced team members.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.
• Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition.
• Familiarity with Computer / Automation systems (MES, Delta-V, SAP, PI data historian)
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Experience participating in, managing, and responding to health authority inspections, partner, and corporate audits.

Minimum Qualifications

• Bachelor's degree in Life Sciences or Engineering with 5+ years of applicable industry experience; OR,
• Master's degree in Life Sciences or Engineering and 3+ years of applicable experience; OR,
• PhD in Life Sciences or Engineering and 1+ years of applicable experience.
• 2+ years of experience in GMP Quality Assurance and/or similar role.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Preferred Qualifications

• Prior Experience and Working knowledge of Trackwise, Veeva, and/or Kneat validation software.
• Knowledge of electronic batch records and review-by-exception practices.
• Prior experience and knowledge with Quality Risk Management principles.
• Advanced Understanding of drug substance manufacturing including cell culture, upstream processes, large scale recovery and/or downstream processes.
• Expertise in cGMP & FDA regulations.
• Experience with startup projects or initiatives.
• Occasional opportunity for International and/or Domestic travel may be available.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• Ability to stand for prolonged periods of time for up to 30 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).