The Metrologist is responsible for all aspects of the QC Laboratory Instrumentation Program. The Metrologist performs or coordinates instrument installation, qualification, repair, troubleshooting, calibration, and maintenance on laboratory equipment, instrumentation, and apparatus.
Organization Structure:
The Metrologist reports to the Manager Quality Control.
Responsibilities:
Instrumentation acquisition and installation
Source equipment and instrumentation for purchase, and coordinate purchase
Author and execute IQ/OQ/PQ protocols in accordance with NPI change control management and validation systems
Author SOPs and related documentation for operation/maintenance of equipment
Maintain appropriate spare parts inventory
Provide training on instrumentation use and maintenance to laboratory analysts
Instrumentation calibration,qualification and maintenance
Perform or coordinate calibration, qualification and maintenance of laboratory equipment/instrumentation
Schedule calibration/maintenance activities of outside vendors and review the work performed by vendors
Ensure that equipments are properly tagged with calibration/qualification or not in service status in accordance with NPI SOP
Instrumentation repair and troubleshooting
Monitor equipment performance throughout lifecycle
Apply technical knowledge and experience to return instrumentation to operational state
Work with outside vendors to facilitate repairs as needed
Provide input to laboratory equipment improvement projects
Compliance activities
Ensures laboratory equipment and instrumentation are compliant with site and industry standards
Perform and document investigations into equipment issues as required by the Quality Investigation System
Participate in laboratory investigations as needed
Participate in audits as needed
Completes corrective and preventive actions assigned by investigations or audit observations
Maintains instrument log books
Provide SAP equipment resource support
Ensure addition of new equipment/instrumentation into SAP Preventive Maintenance System
Schedule and track calibration/preventive maintenance activities
Maintain accuracy of QC resource inventory and calibration/qualification status in SAP
Qualifications:
BS in chemistry, physics, metrology, or related field plus 3-5 years of hands-on laboratory experience, or equivalent combination of education and experience
Significant experience and expertise in equipment maintenance, repair, electronics, and metrological techniques
Excellent oral and written communication skills
Proficient in computer use (Word, Excel, PowerPoint, internet) and able to learn new computer applications
Ability to comprehend and follow standard operating procedures and test methods
Strong analytical aptitude, scientific judgment, and operates with a sense of urgency in a fast-paced environment
Strong organization, communication, and interpersonal skills
GMP Decision Making Authority :
Authors, executes, and reviews instrumentation qualification protocols
Authors, executes, and reviews calibration and maintenance documentation
Authors investigations into non-compliant equipment function
Participates in audits as required
Norwich Pharmaceuticals - 30+ days ago
|
|
2 reviews
With a focus on improving patient outcomes, Norwich is a reliable partner for all stages of the product lifecycle.
Norwich is a recognize...
|
