Lab Support Analyst

Role: Lab Support Analyst

Location: Albany/Rensselaer, NY Onsite

Need GxP environment exp + Lab instrumentation exp.

Excellent communication skills, client facing exp.

Will consider relocation

Virtual Interview Process

********** Lab Instrumentation Validation Analyst
Responsibilities:

• Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
• Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.)
• Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems
• Author validation life cycle documents for client s review and approval
• Route drafted documents for review
• Route reviewed documents for workflow approval
• Request approval workflows to Doc Control
• Execute approved protocols in GxP facility
• Understand SDLC process and SDLC methodology such as agile etc.
• Work with global team in delivering validation project deliverables
• Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area
• Author change control documents for client review and approval

Qualifications:

• Prior experience with benchtop instrument experience is a must
• Bachelor s/ Master s degree or equivalent in a scientific or health care field.
• 7+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.