Facilities and Metrology Compliance Specialist

1 month ago

Durham, United States Humacyte Inc Full time

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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