Metrology Compliance Specialist

4 weeks ago

Raleigh, United States Advanced Recruiting Partners Full time

JOB DESCRIPTION

  • The Metrology Compliance Specialist supports the Metrology Services Department as a part of a rapidly expanding GMP Manufacturing Operation. The Specialist will need to produce high-quality documentation by reviewing of the departments calibration and Maintenance records for accuracy and compliance with the appropriate procedure. The candidate will ensure that department compliance measures are maintained, all documentation meets regulatory requirements, and is completed according the determined target timelines.
  • The Specialist will be responsible for the completion of Metrology Services Change Controls, CAPAs, Deviations, Risk Assessments, SOPs, and other quality documentation. Understand GxPs, nonconformities, Good Documentation Practices, calibration, equipment maintenance, etc. Ensure that SOP, procedures, specifications and calibration and Maintenance dates are current and appropriately captured. Identification of quality issues and ability to take quick corrective action. Assists in the corrective and preventive action process. Verify reverse traceability and to conduct risk assessments when reference standards are found out of tolerance. Communicate information to all relevant departments, outside vendors or contractor.
  • 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.
  • Measure and publish facility’s PI metrics to the management team; interpret data, troubleshoot processes and make recommendations based on findings
  • Coordinates outside calibration activities with vendors.
  • 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 (Deviation, 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.
  • Assist in generation of departmental quality metrics and track the status of active records.

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