Validation & Quality - Katalyst Healthcares and Life Sciences : Job Details

Validation & Quality

Katalyst Healthcares and Life Sciences

Job Location : Rensselaer,NY, USA

Posted on : 2025-08-05T07:37:32Z

Job Description :

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 different stakeholders (IT, Network, Vendor) 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.

Requirements:

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

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