Qualification Specialist / Specific Commissioning and Validation
Hays

Job Info

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Qualification Specialist / Specific Commissioning and Validation in Princeton, MA.

Role Description

• Participate as part of a cross functional global project to qualify QC instruments and associated software.
• 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.
• Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five company QC sites.
• Implement validation strategies for QC instrumentation and associated software, across company QC Laboratories.
• Author qualification related deviations, identifying root causes and robust CAPAs.
• Author qualification related change controls and validation plans.
• Update company procedures and documents to implement data integrity controls arising from instrument qualification programs.
• Serve as liaison with lab-IT teams to harmonize 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.

Skills & Requirements

• Bachelor's degree in relevant scientific or computer area with 3 - 5 years' experience in the biopharmaceutical industry or MS degree with 2 years' experience or equivalent combination of education and experience.
• Minimum 2 years' 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 expertise in large projects
• Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritize 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 travel when required.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

Medical
Dental
Vision
401K
Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer including disability/veteran.

Drug testing may be required; please contact a recruiter for more information. #1139775