QC Compliance QA Specialist — Biotech Lab (Onsite, NC)

NCBioImpact; Holly Springs (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina is seeking a QA Specialist, QC Compliance to drive quality oversight of the QC laboratory program. You will partner with project teams to ensure validation and lifecycle documentation, support regulatory inspections, and optimize quality systems across sites.

The role requires GMP knowledge, strong communication, and the ability to work in a 24/7 manufacturing environment.

Qualifications

• Excellent oral and written communications skills.
• Collaborative attitude to work with global peers and cross-functional teams.
• Understanding of GAMP5, USP <1058>, Data Integrity, and EU Annex 1, 21 CFR Parts 11 and 820.
• Experience in validation of laboratory equipment and systems.
• Knowledge of cGMP compliance and related regulations.
• Strong time management and ability to meet deadlines.
• Critical thinking and problem-solving abilities.
• Team-based attitude and relationship-building.

Responsibilities

• Provides QA oversight and support for project deliverables in the QC laboratory program.
• Assess impact of system and process modifications and maintain site validation state.
• Oversee lifecycle documentation including risk assessments, specs, qualification protocols, validation plans and reports.
• Generate, review, and approve QA procedures for validation and lifecycle documents.
• Generate, review, and approve QA documentation for operational readiness and QA support in cGMP facilities.
• Ensure project and operational quality objectives are met within timelines.
• Collaborate with other FUJIFILM Biotechnologies sites to streamline processes.
• Perform other duties as assigned.

Job description

FUJIFILM Biotechnologies in Holly Springs, North Carolina is seeking a QA Specialist, QC Compliance to drive quality oversight of the QC laboratory program. You will partner with project teams to ensure validation and lifecycle documentation, support regulatory inspections, and optimize quality systems across sites.

The role requires GMP knowledge, strong communication, and the ability to work in a 24/7 manufacturing environment.