QA Specialist, QC Compliance

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, QC Compliance to partner in the Quality oversight of the QC laboratory program. The role drives validation and lifecycle management for lab processes, ensuring systems stay validated and aligned with regulatory expectations.

The candidate will collaborate with global peers, manage risk documentation, and support inspections. A strong background in GMP/QC and validation is required, with flexibility for 24/7 manufacturing

Qualifications

• Bachelor's or Master's degree in Life Sciences or Engineering with GMP-related experience preferred.
• 1-3 years of experience in a GMP environment and/or GMP Quality Assurance roles.
• Experience in validation, cGMP manufacturing operations, and/or QA oversight in an FDA-regulated facility.

Responsibilities

• Provides QA oversight for QC laboratory processes and project deliverables.
• Manages change control and ensures lab systems remain validated from startup through commercial operation.
• Approves laboratory system and process documentation, qualification protocols, validation plans and summary reports.
• Generates and approves QA procedures for validation approaches and lifecycle documents for equipment and systems.
• Ensures timely achievement of project and operational quality objectives and collaborates across sites to streamline processes.

Skills

QA oversight

GMP compliance

Change management

Documentation control

Education

Bachelor's degree in Life Sciences or Engineering

Master's degree in Life Sciences or Engineering

Tools

Trackwise

MasterControl

Kneat validation

Smartsheet

Job description

Position Overview

The QA Specialist, QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist, QC Compliance helps drive Quality oversight for the direction of all QC laboratory processes, from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other project teams and QA departments at other sites to align strategies and procedures. This role ensures QC laboratory systems and processes are operated and maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, as well as QA oversight of day-to-day activities and resolution or mitigation of issues. This role participates in optimization and 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

• Provides QA oversight and support for project deliverables in accordance with the governing processes and procedures for the QC laboratory program.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure laboratory systems are first validated, and then maintained in a validated state through site startup and into commercial operation.
• Provides oversight and approval of laboratory system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for laboratory equipment and systems.
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of laboratory operations in cGMP regulated facilities.
• Ensures that project and operational quality objectives are met within desired timelines.
• Actively seeks opportunities to collaborate and align with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Excellent oral and written communications skills and fluency in English.
• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Understanding of GAMP5, USP < 1058>, Data Integrity, and application of EU Annex 1, 21 CFR Parts 11 and 820 as pertains to lab processes.
• Understanding of validation of laboratory benchtop and support equipment, and methodologies.
• Knowledge and application of cGMP compliance and other related regulations.
• Strong communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to think critically and have superior problem-solving skills.
• Team-based attitude and ability to build relationships and communicate effectively with others.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor's degree in Life Sciences or Engineering with 2+ years of experience; OR,
• Master's degree in Life Sciences or Engineering with 0 years of experience.
• 1-3 years of experience in a GMP environment.
• 1+ 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 ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software.
• Basic experience or understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
• Prior experience and basic understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
• Prior experience or understanding of GAMP5, Data Integrity, and application of 21 CFR Part 280 and Part 11.
• Training and/or familiarity with Quality Risk Management principles.

Physical Requirements:

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 60 minutes.
• Ability to sit for prolonged periods of time for up to 60 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.

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]).