QA Specialist, QC Compliance

Fujifilm • Holly Springs, NC

2d • Onsite

About The Position

The QA Specialist, QC Compliance partners in Quality oversight of the Quality Control area, supporting QC laboratory processes from project phase through operational readiness and overseeing execution of validation programs. The role works with project teams and QA departments at other sites to align strategies and procedures, and ensures QC laboratory systems and processes remain in a validated state throughout their lifecycle. This includes consistent policy administration, oversight of day-to-day activities, and resolution or mitigation of issues. The specialist also participates in optimization and improvement initiatives and supports regulatory agency and third-party inspections.

The role provides QA oversight and support for QC laboratory project deliverables, assesses the impact of system and process modifications, and oversees change management. It reviews and approves lifecycle documentation and QA procedures for laboratory equipment and systems, as well as documentation and processes supporting operational readiness and laboratory operations in cGMP-regulated facilities. The position works to meet project and operational quality objectives within desired timelines and collaborates with other FUJIFILM Biotechnologies sites to streamline processes and improve efficiency. The employee must be flexible to support a 24/7 manufacturing facility.

Requirements

• Bachelor’s degree in Life Sciences or Engineering with at least 2 years of experience, or a Master’s degree in Life Sciences or Engineering with 0 years of experience.
• 1–3 years of experience in a GMP environment.
• At least 1 year of experience in GMP Quality Assurance and/or a similar role.
• Experience in validation, cGMP manufacturing operations, and/or Quality oversight in an FDA-regulated facility.
• Excellent oral and written communication skills and fluency in English.
• Understanding of GAMP5, USP <1058>, data integrity, and application of EU Annex 1 and 21 CFR Parts 11 and 820 as they pertain to laboratory processes.
• Understanding of validation of laboratory benchtop and support equipment and related methodologies.
• Knowledge and application of cGMP compliance and related regulations.
• Strong communication skills to partner with teams and stakeholders.
• Strong time-management skills and ability to meet tight deadlines and prioritize tasks effectively.
• Critical thinking and superior problem-solving skills.
• Collaborative, team-based approach and ability to build relationships and communicate effectively.
• Flexibility to support a 24/7 manufacturing facility.

Nice To Haves

• 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 and IT systems, and related 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.

Responsibilities

• Provide QA oversight and support for project deliverables in accordance with governing QC laboratory program processes and procedures.
• Assess the impact of system and process modifications and oversee change management to ensure laboratory systems are validated and maintained in a validated state through site startup and commercial operation.
• Oversee and approve 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.
• Generate, review, and approve QA procedures for validation approaches and lifecycle documents for laboratory equipment and systems.
• Generate, review, and approve QA documentation, procedures, and processes for operational readiness and QA support of laboratory operations in cGMP-regulated facilities.
• Ensure project and operational quality objectives are met within desired timelines.
• Collaborate and align with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Support regulatory agency and third-party inspections.
• Participate in optimization and improvement initiatives.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level