QC Analytics & Operations Specialist (Lab Systems)

Regeneron Pharmaceuticals, Inc (USA); City of Saratoga Springs (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Saratoga Springs, NY, is hiring multiple Quality Analytical Technology & Operations Specialists to join the Quality Control team at our new automated drug substance facility.

The role emphasizes data integrity, lab system integration, and qualification testing across 1st shift with domestic travel. Candidates should have a BS/BA in Engineering, Chemistry, or Life Sciences, with 0–5+ years depending on level.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; substitution allowed for experience.
• 0–2+ years for Assoc Analyst role; 2+ years for Analyst; 5+ years for Sr. Analyst; level based on experience.
• Familiarity with data integrity (ALCOA+), 21 CFR Part 11, Annex 11, and GxP requirements.
• Exposure to laboratory system integration CDS, LIMS, instrument interfacing, or data acquisition preferred.

Responsibilities

• Gather inputs to assay-to-space model: equipment lists, footprint measurements.
• Document User Requirement Specification content; note integration details.
• Maintain integration documentation for lab systems connecting to lab bus; flag gaps.
• Document material, sample and personnel flow from receipt to waste.
• Support risk assessments by collecting evidence and organizing findings.
• Prepare materials and impact docs for design reviews and VE changes.
• Coordinate instrument delivery, installation, and FAT/SAT activities.
• Execute qualification protocols and acceptance testing for lab functionality.
• Support LIMS configuration and digital lab integration tasks.
• Draft and revise SOPs for access, sample handling, and waste management.
• Assist in dry runs of sample-to-result path and engineering runs.
• Provide post-handover support to QC testing; triage issues and support change control.

Skills

Analytical thinking

Documentation

Quality systems

Data integrity

Collaboration

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

LIMS

CDS

Lab instrumentation

Job description

Regeneron Pharmaceuticals, Inc. in Saratoga Springs, NY, is hiring multiple Quality Analytical Technology & Operations Specialists to join the Quality Control team at our new automated drug substance facility.

The role emphasizes data integrity, lab system integration, and qualification testing across 1st shift with domestic travel. Candidates should have a BS/BA in Engineering, Chemistry, or Life Sciences, with 0–5+ years depending on level.