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28 Oct 2020

Temporary QC Instrument and Software Validation Specialist (20-16793)

Axelon Services Corporation – Posted by Devens, Massachusetts, United States

Job Description

Job Description:

• Participate as part of a cross functional global project to qualify QC instruments and associated software.
• Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five Client QC sites.
• Implement validation strategies for QC instrumentation and associated software, across Client QC Laboratories.
• Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as;
• Network QC Instrumentation Standardization and Windows 10 upgrades.
• Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments.
• Author qualification related deviations, identifying root causes and robust CAPAs.
• Author qualification related change controls and validation plans.
• Update Client procedures and documents to implement data integrity controls arising from instrument qualification programmes.
• Serve as liaison with lab-IT teams to harmonise QC instrument’s software configurations where applicable
• Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
• Provide updates on qualification status, project timelines, and escalate challenges as required.
• Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team

Qualifications and Experience required:
• Minimum of 2 years’ experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role.
• Demonstrated expertise in large projects within a complex high performance team,
• Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
• Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects.
• Self-directed with a high degree of professional integrity, organization, and attention to detail.
• Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
• Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
• Ability to work across timelines and be available to travel when required.
• Demonstrated use of flexible thinking and growth mind-set is an advantage.

Candidate is expected to display the behaviors, which enable them to be successful and perform at their highest level:
• Passion: We pursue excellence to help patients prevail.
• Innovation: We embrace new ideas.
• Accountability: We own our outcomes and the outcomes of others.
• Speed: We act with urgency and agility.

How to Apply

Please send your updated resume to

Job Types: Temporary.

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