bioMerieuxBahama
Organize, administrate, optimize Maintenance Management and Production Maintenance activities, and oversee Project Management. Manage and oversee Preventive Maintenance, Corrective, & Urgent Maintenance workflow and activities in the Blue Mountain CMMS.
Reduce the cost of maintenance and optimize de...
Eurofins USA BioPharma ServicesCary, 17 mi from Durham
Quality Assurance I roles
maintaining all Master Lists
maintaining Control of Specifications
assisting with writing and approving internal documents
Supports Equipment Control by:
maintaining identification and calibration labels/cards
reviewing and approving...
LanceSoft IncMebane, 22 mi from Durham
calibration.
• Work with manufacturing personnel to accurately complete required Quality Control (QC) testing, documentation and determine correct disposition.
• Detect nonconforming conditions during inspection and accurately document each condition...
eTeam Inc.Mebane, 22 mi from Durham
verify accuracy and completeness of documentation, and confirm equipment used meets designated specifications including calibration.
Work with manufacturing personnel to accurately complete required Quality Control (QC) testing, documentation...
Army National GuardButner
As overseers of electricity, Interior Electricians are valuable to the operations of the Army National Guard. As an Interior Electrician, you will install and wire electrical hardware like transformers, junction boxes, service panels, electrical boxes, switches, and circuit breakers.
After 10 weeks ...
CornerStone StaffingCary
Do you have experience working In the Medical Field? Do you enjoy providing superior customer service while handling heavy inbound calls,? CornerStone Staffing is seeking candidates that will assist with schedule refills, patient updates, and healthcare assistance.If you have this experience, APPLY ...
Insight GlobalDurham
Required Experience:
• 2+ years of experience working with GMP manufacturing/processes
• 5+ years of experience with Calibrations
• Experience with a work order management system similar to SAP, Blue Mountain, Maximo, ProCal
• Must be able...
The Boyd GroupRaleigh, 21 mi from Durham
collision repair facility in the identification and execution of safety operations
• Performs diagnostic testing, programming, ADAS calibrations and analysis
• Performs wiring, connector, and harness repairs
• Delivers completed invoices and payments...
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Metrology Compliance Specialist
Durham | www.resume-library.com |
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.
#IND
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.
#IND
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