IT Lab Systems Specialist
SGS North America Inc.

Job Info

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Company Description

SGS is the world's leading inspection, verification, testing, and certification company. We arerecognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

The IT Lab SystemsSpecialist will validate all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocols. You will also ensure data integrity and compliance to 21CFR Part 11 and GxP standards.
A day in the life of a Pharmaceutical IT Lab SystemsSpecialist at SGS:

• Install/update/troubleshootinstrument software andmalfunctions require MS Windows/network troubleshooting skills
• Review and pilot testing of new software and instrument systems as part of system implementations
• Review and remediate non-compliance and audit issues for data integrity compliance on the computerized systems in the lab
• Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocols
• Data integrity and compliance to 21CFR Part 11 and GxP standards
• Prepare draft and final SOPs and compliance documents
• Liaise with and management activities of laboratory instrument and software vendors
• Develop validation protocols where not provided by the vendor
• Review and recommend changes to improve the efficiency of automated systems
• Adheres to internal standards, policies, and procedures.
• Performs other duties as assigned.

Qualifications

• Bachelor's degree in Science, IT, Engineering or equivalent experience
• 2+ years experience administering laboratory instruments and lab software applications
• Experience should include the pharmaceutical laboratorysystems such as Waters Empower and/or Open Lab CDS systems, Agilent, Waters, Thermo Fischer with typical instrumentation such as GC, HPLC, ICP-MS, MS/MS, Spectrophotometers, FTIRs
• Experience in instrument software setup, configuration, and qualifications in a GxP / biological laboratory environment.
• Experience in troubleshooting Windows and network-related issues with instrument software configurations
• LIMS systems administration and configuration
• Working knowledge of GxP regulations and regulatory standards for computer systems validations

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