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About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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 , 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
More about this role
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.
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,...
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