• Supervisor, QA Operations - Nights

    Fujifilm (Holly Springs, NC)
    …substance manufacturing processes * Familiar with Technology Transfer and/or Product Commercialization processes * High level of familiarity/understanding of ... manufacturing & IT Systems, and/or validation methodologies * Understanding of GAMP5, Data Integrity , and application of 21 CFR Part 820 and Part 11 * Occasional… more
    Fujifilm (04/03/25)
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  • Sr. Engineer, QA Operations (Tech Transfer)

    Fujifilm (Holly Springs, NC)
    …Development and approval of TT Gap assessment(s) b. Oversight of New Product Introduction (including Change Management mechanisms, as applicable) c. Approval of ... automation, manufacturing & IT Systems, and/or validation methodologies * Understanding of Data Integrity , and application of 21 CFR Part 820 and Part 11 *… more
    Fujifilm (03/30/25)
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  • Associate Manager, QA Operations

    Fujifilm (Holly Springs, NC)
    …Leads cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based, right-size approach. * Collaborates ... manufacturing & IT Systems, and/or validation methodologies * Understanding of GAMP5, Data Integrity , and application of 21 CFR Part 820 and Part 11 * Training… more
    Fujifilm (03/12/25)
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