QC Lab Analytics & Systems Specialist

Regeneron Pharmaceuticals; Saratoga Springs (UT); On-site; USD 62,000 - 131,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron Pharmaceuticals in Saratoga Springs, NY is hiring multiple Quality Analytical Technology & Operations Specialists to join the Quality Control team at our new highly automated drug substance manufacturing facility. This role supports IQ/OQ/PQ, LIMS configuration, and lab system integrations to ensure data integrity and compliant operations.

Responsibilities include documenting workflows, coordinating instrument delivery and testing, drafting SOPs, and assisting in change control while

Qualifications

• Requires familiarity with ALCOA+ data integrity, 21 CFR Part 11, Annex 11, and GxP.
• Experience with laboratory data systems and instrument interfaces is preferred.
• Ability to document requirements, SOPs, and change controls with precision.

Responsibilities

• Gather inputs for assay-to-space model, equipment lists, and footprints.
• Support User Requirement Specification content and integration decisions.
• Maintain lab system integration documentation and flag data gaps.
• Document material, sample, and personnel flow from receipt to retention and waste.
• Assist with data integrity risk assessments and organize findings for review.
• Prepare materials for design reviews and value-engineering changes.
• Coordinate instrument delivery, installation, and FAT/SAT activities.
• Execute qualification protocols and acceptance testing for lab functionality.
• Support LIMS configuration and lab bus integration tasks.
• Draft SOPs for the assigned space including sample handling and waste management.
• Assist in dry runs of sample-to-result path and engineering runs.
• Provide post-handover support to site QC testing and participate in change control.

Skills

Data integrity ALCOA+

GxP knowledge

Lab system interfacing

Documentation

Education

BS/BA in Engineering, Chemistry, Life Sciences

Tools

LIMS

CDS

Instrument interfacing

Job description

Regeneron Pharmaceuticals in Saratoga Springs, NY is hiring multiple Quality Analytical Technology & Operations Specialists to join the Quality Control team at our new highly automated drug substance manufacturing facility. This role supports IQ/OQ/PQ, LIMS configuration, and lab system integrations to ensure data integrity and compliant operations.

Responsibilities include documenting workflows, coordinating instrument delivery and testing, drafting SOPs, and assisting in change control while