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    Facilities and Metrology Compliance Specialist

    • Humacyte
    • Full time
    • Durham, North Carolina
    • Posted: June 30, 2024
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    Company
    Humacyte

    The Facilities and Metrology Compliance Specialist supports the Engineering, Facilities and Metrology Service Departments as a part of a rapidly expanding GMP Manufacturing Operations.

    The Specialist will need to:

    • Produce high-quality documentation by reviewing the departments Metrology and Maintenance records for accuracy and compliance with the appropriate procedure.
    • Ensure that department compliance measures are maintained, all documentation meets regulatory requirements, and is completed according to the determined target timelines.
    • Ensure departmental compliance by routinely checking maintenance, metrology and cleaning logbooks.
    • Be responsible for the completion of Department Change Controls, CAPAs, Quality Events, Risk Assessments, SOPs, and other quality documentation.
    • Ensure that SOP, procedures, specifications are appropriately captured and reviewed.
    • Have a strong understanding of GxPs, remediating nonconformities, follow Good Documentation Practices, have a strong background in calibration, equipment maintenance, etc.
    • Support the Metrology department by helping with conducting reverse traceability and to conduct risk assessments when reference standards are found out of tolerance.
    • Support the site’s general cleaning activities to ensure compliance, by checking all documentation including review and approval of the sites cleaning logbooks.
    • Excellent communication skills, ability to lead investigation teams and meet all deadlines.
    • Track KPI’s for the Engineering, Facilities and Metrology departments to ensure compliance, and efficiency in a timely manner. Additional duties include the writing, review, approval, and maintenance of GMP and non-GMP documentation including Standard Operating Procedures (SOPs), Non-Conformance reports, and calibration records.

    Major Accountabilities

    • Partner with Quality, Engineering and Operations groups to always ensure strict compliance with CMMS cGMP/GLP guidelines.
    • Measure and assist with reporting of KPI metrics daily/weekly by improving processes, helping interpret facts and data, and by making sound recommendations based on quantitative and qualitative data.
    • Help with coordination with outside vendors to schedule activities and communicate these activities within the department.
    • CAPA System: Utilize this quality system to evaluate identifiable factors to solve problems diverse in scope and implement continuous improvement corrective and preventive actions for system level improvements.
    • Change Control System: Identify and initiate changes through collaborative efforts with Quality Assurance and applicable departments in response to deviations, CAPA’s and departmental continuous improvement projects.
    • Utilizes multifunctional teams to implement process and continuous improvements within Quality Systems (Quality Events, CAPA, CC, SOPs, Risk Analysis, Root Cause Analysis, etc.)
    • Support Facility Maintenance, and Metrology in the development and revision of Standard Operating Procedures (SOPs), completion of periodic reviews, and other quality documentation.
    • Other duties, as assigned.

    Specific Skills

    • Basic understanding and application of instrument, equipment, calibration, and maintenance of various parameters in manufacturing, utilities, and laboratory environments within a cGMP Biotechnology / Pharmaceutical manufacturing environment.
    • Understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios.
    • Able to make independent decisions within defined scope of work, seeks clarification and directions when needed. Must be self-driven and demonstrate ability to work with little direction.
    • Proven knowledge of a Computerized Maintenance Management System (CMMS).
    • Strong organizational and planning skills required.
    • Excellent interpersonal effectiveness and communication skills (written and oral) are required to interface across management levels and departments.
    • Works as a team player and serves as a model by participating in activities that involve cooperating with others.
    • Engineering
    • Management

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