Quality Assurance Validation Specialist
Description:
Role: Quality Assurance Validation Specialist
Duration: 6+ Months
Location: Rensselaer, NY
Job Description:
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
Qualifications:
Prior experience with benchtop instrument experience is a must
Bachelor’s/ Master’s degree or equivalent in a scientific or health care field.
5+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.