QC Analytical Tech & Operations Specialist

BioSpace; City of Saratoga Springs (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron is hiring for an Analytical Technology & Operations Specialist to support QC lab builds, relocations, and automation at a new facility in Saratoga Springs. The role covers IQ/OQ/PQ, LIMS integration, and design documentation, with heavy emphasis on cGMP and ALCOA+ compliance.

You will help maintain lab workflows, support instrument qualification, and collaborate with QA, Engineering, and IT to minimize disruption and ensure data integrity across the lab bus.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience acceptable.
• Experience with lab informatics, data integrity and quality systems.

Responsibilities

• Gather inputs for assay-to-space model and equipment lists.
• Document equipment/network integration details and escalate decisions.
• Maintain integration docs for lab systems and data flow.
• Document sample, material, and personnel flow per approved maps.
• Support data integrity risk assessments and track findings.
• Prepare material for design reviews and change proposals.
• Coordinate instrument delivery, installation, and FAT/SAT.
• Execute qualification protocols and acceptance testing for lab functions.
• Support LIMS configuration and digital lab integration.
• Draft SOPs for space access, gowning, and sample handling.

Skills

GxP knowledge

Data integrity (ALCOA+)

21 CFR Part 11

Process validation

Quality systems collaboration

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

LIMS

CDS

Lab automation

Instrument interfacing

Job description

Regeneron is hiring for an Analytical Technology & Operations Specialist to support QC lab builds, relocations, and automation at a new facility in Saratoga Springs. The role covers IQ/OQ/PQ, LIMS integration, and design documentation, with heavy emphasis on cGMP and ALCOA+ compliance.

You will help maintain lab workflows, support instrument qualification, and collaborate with QA, Engineering, and IT to minimize disruption and ensure data integrity across the lab bus.