Senior Quality Assurance Specialist
6 days ago
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team in Albany, NY. As a key member of our Laboratory IT team, you will be responsible for creating and supporting review of validation life cycle documents for Analytical Instrument Qualification and computerized systems.
About the RoleThe ideal candidate will have prior experience with benchtop instrument validation and a Bachelor's or Master's degree in a scientific or health care field. A minimum of 5 years' experience in a Validation/Quality assurance/control role is required, preferably in the pharmaceutical/Life sciences industry.
Key Responsibilities:
- Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
- 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
We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. The estimated salary for this position is $85,000 - $110,000 per year, depending on experience.
About ZifoZifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies.
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