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    1 month ago

    Durham, United States Technical Source Full time

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    23 hours ago

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    22 hours ago

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    3 months ago

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    6 days ago

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Facilities and Metrology Compliance Specialist

2 months ago

Durham, United States HUMACYTE GLOBAL INC Full time

Job Description

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.

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